MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH¿ TELESCOPE, 4 MM, 0°, CONNECTOR FOR LIGHT GUIDE ON BOTTOM, AUTOCLAVABLE

Model Number	WA96200A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that during maintenance they discovered that the lens was shattered.There were no reports of patient harm associated with this event.
Additional Manufacturer Narrative
The device was returned to olympus and the customer¿s complaint (shattered lens) was confirmed, the distal lens was broken.Additionally, testing and inspection found the following: bent outer tube, debris in the optical fiber system, scratches on the distal end, damaged inner adapter.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, the identified fault patterns are most likely attributable to the use of excessive force by the customer.However, the specific root cause could not be determined at this time.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, 4 MM, 0°, CONNECTOR FOR LIGHT GUIDE ON BOTTOM, AUTOCLAVABLE
• Common Device Name: TELESCOPE
• 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: 17039332
• Report Number: 3003724334-2023-00011
• Device Sequence Number: 12489730
• Product Code: EOB
• UDI-Device Identifier: 04042761070027
• UDI-Public: 04042761070027
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K944072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,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: WA96200A
• Device Catalogue Number: WA96200A
• Device Lot Number: 800975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2022
• 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