MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT SINGLE USE DISTAL COVER

Model Number MAJ-2315

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

An olympus representative reported that when conducting a field visit, the customer reported at times, there was a crack when attaching a single use distal cover.The event occurred during preparation for use and the procedure was completed with a similar device.There was no patient harm associated with the event.This report is linked to the following patient identifier: (b)(6).

Manufacturer Narrative

The device is not expected to be returned for evaluation.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the cause of the distal cover damage that occurred at the facility could not be definitively determined.Since olympus confirmed the distal cover will not be damaged if it can be attached correctly according to the procedure in the instruction manual, it is likely the damage to the distal cover occurred was caused by the following handling by the user: -chemicals such as anti-fog agents adhered to the distal cover, causing damage due to chemical attack.-minor damage caused by pushing the cover diagonally when attached to the endoscope.In addition, olympus believes the actual product satisfies the specifications.Basis for assuming that user handling is the cause: -as a result of the operation confirmation, it was confirmed that if the distal cover is attached in the correct procedure, it will not be damaged.-as a result of the labeling review, the instruction manual describes chemical attack by anti-fog agents and pushing diagonally when installing as handling factors that lead to breakage of the distal cover.However, since olympus was unable to confirm detailed information regarding the handling of these, we cannot completely deny these factors.Basis for assuming that the actual product satisfies the specifications: -as a result of the type test, olympus verified that "the distal cover does not break during attachment and use" in the evaluation at the development stage, and confirmed that the product satisfies the specifications.-in the parts manufacturer's inspection, after attaching the distal cover, push and pull loads are applied to the distal cover, and it is confirmed that there is no damage such as tearing or chipping in the distal cover.The cause of the damage (crack) was presumed to be insufficient attachment to the scope and chemical cracks caused by chemicals such as anti-fog agents.Olympus confirmed the handling precautions for these factors are described in the instruction manual as follows: "do not apply anti-fogging products, olive oil, or products containing petroleum-based substances (e.G., vaseline®) to the distal cover and the endoscope.These products may cause cracks of the distal cover." " push the center on the top of the distal cover.Otherwise, it may cause the break of the portion on the distal cover such as the tear off line." olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE DISTAL COVER
• Type of Device: DISTAL COVER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo 190-0 182; JA 190-0182
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17454967
• MDR Text Key: 321523270
• Report Number: 3003637092-2023-00164
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170403019
• UDI-Public: 04953170403019
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K220587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-2315
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 08/09/2023
• Supplement Dates FDA Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1