MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE "TRUEVIEW II", 4 MM, 0°, AUTOCLAVABLE; RIGID SCOPE

Model Number	A70940A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1/establishment name: (b)(6) added here due to character limitation in respective field.To date, the device has not been returned to olympus for evaluation.The investigation is ongoing.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, the connector was torn off of the olympus rigid scope.The issue was found during preparation for use for an unknown procedure.The procedure was completed with a similar device.There was no report of patient injury or medical intervention associated with this event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: d8, d9, h6, h11.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The customer's complaint was not confirmed.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that "connector is torn off" occurred due to excessive use or the impact of a major mechanical force caused a blow or a fall.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE "TRUEVIEW II", 4 MM, 0°, 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: 18229601
• Report Number: 9610773-2023-03420
• Device Sequence Number: 12329372
• Product Code: HRX
• UDI-Device Identifier: 04042761010535
• UDI-Public: 04042761010535
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K951354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2024

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: A70940A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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