MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 4 MM, 12°, LONG; AUTOCLAVABLE TELESCOPES

Model Number	WA20021A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being supplemented to provide information, based on the device evaluation and the legal manufacturer's final investigation of a reportable event.Device was returned.And the customer's allegation was confirmed.The device evaluation found a broken lens.These damages can be attributed to excessive force by the customer.Based on the results of the investigation, it is likely, that the following led to the malfunction: the reported failure mode/identified defect(s) can be attributed to improper handling and application of excessive force, impact to the device like fall, shock or similar stress.However, a definitive root cause cannot be identified.A device history review revealed, no issues that could have caused or contributed to the reported issue.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
It was reported, the telescope optic had a crack.There were no reports of patient harm associated with the event.

• Brand Name: TELESCOPE, 4 MM, 12°, LONG
• Common Device Name: AUTOCLAVABLE TELESCOPES
• 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: 20152301
• Report Number: 9610773-2024-02138
• Device Sequence Number: 8302034
• Product Code: GCP
• UDI-Device Identifier: 04042761051422
• UDI-Public: 04042761051422
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K897003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/05/2024

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: WA20021A
• Device Lot Number: 800994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• 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