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

Model Number A22001A

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Event Description

It was observed that during the device evaluation, the rigid scope's objective lens was damaged.There were no reports of patient involvement.

Manufacturer Narrative

The device was returned and the evaluation found that no additional reportable malfunctions other than those mentioned in b5.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final 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 investigation, it is likely the reported failure occurred due to the effect of an excessive mechanical force caused by an impact or fall.However, a specific root cause of the reported event could not be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 12°, 4 MM
• Type of Device: HYSTEROSCOPE, GYNECOLOGY
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg/de/germany 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg/de/germany
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18888316
• MDR Text Key: 337479615
• Report Number: 9610773-2024-00690
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020848
• UDI-Public: 04042761020848
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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: Other
• Device Model Number: A22001A
• Device Lot Number: 638754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 05/15/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2013
• 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