MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH¿ TELESCOPE "IR", 5.4 MM, 30°; RIGID OPTICAL LAPAROSCOPE

Model Number	WAIR530A
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus the telescope "ir", 5.4 mm, 30° l - shape adapter is stuck, and the light guide connector part will not come off.There was no patient/user harm or injury reported due to the event.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was able to be confirmed.During the device evaluation it was observed that the light guide connector was removed, and the l shaped adapter is fixed and will not come off.Additionally, it was observed that the outer tube had a dent.These findings were due to user handling.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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 that the event occurred due to user error, improper handling as well as application of excessive force.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being submitted to correct the legal manufacturer's contact information and facility registration number.The facility registration number is 9610773.

• Brand Name: TELESCOPE "IR", 5.4 MM, 30°
• Common Device Name: RIGID OPTICAL LAPAROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH¿; kuehnstrasse 61¿; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH¿; kuehnstrasse 61¿; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17390203
• Report Number: 3003724334-2023-00015
• Device Sequence Number: 21068443
• Product Code: GCJ
• UDI-Device Identifier: 04042761086189
• UDI-Public: 04042761086189
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2024

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
• Operator of Device: Health Professional
• Device Model Number: WAIR530A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 01/10/2024; 07/01/2024
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 01/15/2024; 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2022
• 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