MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "TRUEVIEW II", 4 MM, 70°, AUTOCLAVABLE; RIGID SCOPE

Model Number	A70942A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
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 broken lens (plan glass) at distal end.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus, that the scope had a damaged lens.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information obtained from the customer (via b3 and b5), results of the legal manufacturer's investigation, and correction to d5.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 phenomenon likely occurred due to excessive force by the customer.Olympus will continue to monitor the field performance for this device.
Event or Problem Description
The customer reported to olympus, that the scope had a scratched lens.The event was found prior to a diagnostic endoscopy procedure.There were no reports of delay or patient harm.

• Brand Name: TELESCOPE "TRUEVIEW II", 4 MM, 70°, 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: 17076475
• Report Number: 9610773-2023-01571
• Device Sequence Number: 6274001
• Product Code: HRX
• UDI-Device Identifier: 04042761010559
• UDI-Public: 04042761010559
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K951354
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2023

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: A70942A
• Device Catalogue Number: A70942A
• Device Lot Number: 605957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2023
• 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: 05/09/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2010
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown