MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 70°, 4 MM; TELESCOPES, AUTOCLAVABLE (WITHOUT CHANNEL)

Model Number A22003A

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device has already been returned to olympus.However, since the evaluation/investigation is still ongoing, the exact cause of the user's experience and the reported phenomenon has not been determined yet.This report will be updated if additional significant information becomes available or once the evaluation/investigation has been completed.

Event Description

The rigid scope was returned to olympus for repair with broken and burned light guide connector.There is no indication that broken parts fell into the patient¿s body or that the reported damage occurred during a procedure and there was no report about an adverse event or patient injury.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to a1, e1, d8,d9, g2 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the reported event is unable to be determined.However, the cause of the event is likely due to inadequate reprocessing resulting in the remaining residues are burned in by the light energy and the associated heating.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was returned to olympus for inspection, and the customer's complaint was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the reported event is unable to be determined.However, the cause of the event is likely due to inadequate reprocessing resulting in the remaining residues are burned in by the light energy and the associated heating.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 70°, 4 MM
• Type of Device: TELESCOPES, AUTOCLAVABLE (WITHOUT CHANNEL)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 16076788
• MDR Text Key: 306683755
• Report Number: 9610773-2022-00814
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K897003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22003A
• Device Catalogue Number: A22003A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1