MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BIOPSY FORCEPS, 5 FR., SEMI-FLEXIBLE

Model Number	A2499
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned to olympus, however, a photograph provided of the suspect device shows the tie rod is cracked and deformed at the connection to handle side.No other defects were observed.The review of the device history records for the affected lot or serial number without showing any non-conformities or deviations regarding the described issue.The device wa s manufactured according to valid instructions and met all specifications.The investigation is still in progress; however, if additional information becomes available, this report will be supplemented accordingly.In general, the end-user is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.
Event or Problem Description
The customer reported the semi flexible biopsy forceps is broken.The problem was caused by incorrect handling by the customer during reprocessing.No death or injury and no impact to patient or other has been reported to olympus.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The following fields were corrected based on available information at the time of the initial report submission: e1 "telephone" was missing and h6 "type of investigation" had selected "10 - testing of actual/suspected device." correction to g2, other report source, from c23154804 to czech republic.Although the device was not returned for evaluation, it is likely the result of improper handling (excessive force) by the user.However, a definitive root cause could not be established.Olympus will continue to monitor field performance for this device.

• Brand Name: BIOPSY FORCEPS, 5 FR., SEMI-FLEXIBLE
• Common Device Name: BIOPSY FORCEPS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 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: 16781833
• Report Number: 9610773-2023-01088
• Device Sequence Number: 6417213
• Product Code: GCP
• UDI-Device Identifier: 04042761003476
• UDI-Public: 04042761003476
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K790071
• 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): 06/28/2023

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: A2499
• Device Catalogue Number: A2499
• Device Lot Number: 21901
• Was Device Available for Evaluation?: No
• 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: 03/26/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• 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