MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 30°, WIDEANGLE, 4 MM; HYSTEROSCOPE

Model Number A22005A

Device Problem Material Integrity Problem (2978)

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

Event Date 03/06/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the rigid scope had a broken camera.There were no reports of patient harm.

Manufacturer Narrative

The subject device has been returned to an olympus repair center for evaluation and inspection.During the device evaluation the customer allegation was confirmed.The evaluation also found, moisture under distal cover glass, outer tube was bent at proximal end, the objective window had fiber breakage and moisture under distal cover glass, the window unit and funnel/cup had minor scratches on the funnel and the optical fiber system had a blurry image.This investigation is ongoing, follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Sections e2, e3, and g2 were corrected with information that was inadvertently omitted from the initial report.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 definitive root cause of the broken camera could not be determined.It is possible that the damage was caused by excessive force from the user.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 30°, WIDEANGLE, 4 MM
• Type of Device: HYSTEROSCOPE
• 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: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16685731
• MDR Text Key: 313035807
• Report Number: 9610773-2023-00972
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020886
• UDI-Public: 04042761020886
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22005A
• Device Catalogue Number: A22005A
• Device Lot Number: 720061C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2016
• 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