MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 12°, 4 MM; RIGID SCOPE

Model Number A22001A

Device Problem Component Missing (2306)

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

Event Date 05/12/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and repair.During the evaluation, the following was found: bent, corrosion on outer tube, dents on distal end, light guide post glass was missing.In addition, dents and scratches were observed on the objective frame as well as fiber breakage.Debris was found in the optical.The investigation is still in progress; therefore, the root cause of the reported defect cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.Olympus will continue to monitor the field performance of this device.

Event Description

It was reported to olympus that a telescope had a light post with damaged glass and missing where it attaches.The reported issue occurred during reprocessing of the device.There was no patient injury or adverse event reported to olympus.

Manufacturer Narrative

H4 ¿ the device manufacturer date remains unknown/unavailable.This report is being supplemented to provide additional information based on the legal manufacturer's investigation.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 legal manufacturer's investigation, a definitive root cause of the reported event could not be identified.However, it's likely the cause is related to excessive use.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 12°, 4 MM
• Type of Device: RIGID SCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17044049
• MDR Text Key: 316758176
• Report Number: 9610773-2023-01511
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020848
• UDI-Public: 04042761020848
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K897003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

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: A22001A
• Device Catalogue Number: A22001A
• Device Lot Number: 300113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 06/01/2023
• Supplement Dates Manufacturer Received: 03/11/2024
• Supplement Dates FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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