MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 5.4 MM, 0°, AUTOCLAVABLE; RIGID SCOPE

Model Number	WA50372B
Medical Device Problem Codes	Disconnection (1171); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the light guide (lg) connection part on the rigid scope was disconnected.The issue was found during preparation for use for a therapeutic laparoscopic surgery.The procedure was completed with a similar device.There were no reports of delay.There were no reports of patient harm.
Additional Manufacturer Narrative
The subject device was returned to an olympus repair center for evaluation and the customer¿s reported problem was confirmed.Device evaluation found the light guide ( lg) connection part was disconnected.The device evaluation also found that the outer tube was bent and there was foreign matter adhesion on the internal lens.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Additional 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 event occurred due to the user improperly handling and applying excessive force to the subject device.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the corrected information.Corrected data: d4 (serial number).

• Brand Name: TELESCOPE, 5.4 MM, 0°, AUTOCLAVABLE
• Common Device Name: RIGID SCOPE
• 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: 17210893
• Report Number: 9610773-2023-01741
• Device Sequence Number: 15036057
• Product Code: GCJ
• UDI-Device Identifier: 04042761029599
• UDI-Public: 04042761029599
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K923982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2023

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
• Operator of Device: Health Professional
• Device Model Number: WA50372B
• Device Catalogue Number: WA50372B
• Device Lot Number: 547916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2023
• Supplement Date Received by Manufacturer: 09/26/2023; 10/02/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 09/28/2023; 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown