MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 0°, HD, QUICK LOCK, AUTOCLAVABLE; LAPAROSCOPE

Model Number WA53000A

Device Problem Break (1069)

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

Event Date 09/20/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was not confirmed.The device evaluation found the light guide connector was detached and missing, the lens was displaced, and there was foreign material inside the device.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus, the telescope, had a broken light guide connector.The issue was found during reprocessing.There were no reports of patient harm.

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.It has been over 15 years since the subject device was manufactured.Based on the results of the investigation, root cause of the reported damage is consistent with excessive mechanical force caused by a shock or fall.However, specific root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 10 MM, 0°, HD, QUICK LOCK, AUTOCLAVABLE
• Type of Device: LAPAROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17902374
• MDR Text Key: 325235753
• Report Number: 9610773-2023-02853
• Device Sequence Number: 1
• Product Code: EWY
• UDI-Device Identifier: 04042761052757
• UDI-Public: 04042761052757
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K950076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA53000A
• Device Lot Number: 555822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2008
• 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