Devices

2 Olympus Endoscope Warning Letters

David McFarland

— 2 min read
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FDA inspections at two Olympus medical device manufacturing facilities in Japan led to separate Warning Letters. A just-released 12/12/22 Warning Letter was issued to Olympus Medical Systems Corp. following a 9/6-9/9/22 inspection at the firm’s Tokyo, Japan, facility that manufactures gastrointestinal and surgical endoscopes. The letter says the devices are misbranded because the company did not follow Medical Device Reporting requirements.

FDA says Olympus failed to submit a report to the agency no later than 30 days after it first received or became aware of information from any source reasonably suggesting that a device that it markets has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

FDA says the adequacy of the firm’s response to the inspection finding could not be determined because Olympus is continuing to implement its corrective actions.

A Warning Letter also was issued to Aizu Olympus Co. in Tokyo, Japan, following a 7/5-7/8/22 inspection that determined that the firm manufactures sterile and non-sterile endoscopes and automated endoscope reprocessors. The letter says the devices did not conform with Quality System regulation requirements. Specific violations were:

  • failing to establish and maintain procedures for validating the device design to ensure that devices conform to defined user needs and intended uses, including testing of production units under actual or simulated use conditions;
  • failing to ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process is validated with a high degree of assurance and approved according to established procedure;
  • failing to establish and maintain procedures to ensure that design history records for each batch, lot, or unit are maintained to demonstrate that a device is manufactured in accordance with the design master record; and
  • failing to develop, maintain, and implement written Medical Device Reporting procedures.

CDRH director Jeff Shuren noted in a statement that the two Warning Letters are the “most recent in the history of CDRH’s compliance actions against Olympus related to MDR and quality system requirements. CDRH has been involved in extensive and ongoing efforts with Olympus to address compliance issues related to the reprocessing of endoscopes. However, as described in the recent Warning Letters, Olympus is not in compliance with MDR reporting and quality system requirements.”

He said that compliance with quality system requirements for endoscopes is “necessary to ensure these devices are designed, validated, and manufactured in a manner that allows for their safe and effective use, including completion of acceptable reprocessing validation and adequate instructions for use. CDRH will continue to ensure that Olympus fully addresses the violations described in the Warning Letters.”

The firm was told to respond with a list of specific actions taken to correct the noted violations and prevent their recurrence, with documentation of the corrections and a schedule for completing them.

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