MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OP-TELESCOPE, 30°, 4 MM CHANNEL; OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE

Model Number	WA33036A
Medical Device Problem Codes	Crack (1135); Poor Quality Image (1408)
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 that the op-telescope, 30°, 4 mm channel had the lens detached.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation, and the customer¿s allegation was not confirmed.The evaluation found the following reportable issues: the plan glass at the distal end is scratched and cracked resulting in a distorted image which was caused by a shock.The investigation is ongoing and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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 excessive force/mishandling by the customer caused the scratched/cracked plan glass.The root cause was unable to be determined for the detached lens, since that was unable to be confirmed during investigation.Olympus will continue to monitor field performance for this device.

• Brand Name: OP-TELESCOPE, 30°, 4 MM CHANNEL
• Common Device Name: OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE
• 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: 18060825
• Report Number: 9610773-2023-03157
• Device Sequence Number: 15385917
• Product Code: FGA
• UDI-Device Identifier: 04042761051866
• UDI-Public: 04042761051866
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K853486
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

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: WA33036A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2011
• 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