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

Model Number	A2500
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation, however, photo of the subject device was provided for evaluation.In addition, according to the report via phone, the field service engineer (fse) physical inspection found the device had broken jaws , broken connection to the control rod.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over a year since the subject device was manufactured.Based on the results of the investigation, it is likely that the following led to the malfunction: improper handling by the user.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
The customer reported to olympus, the grasping forceps had a broken end.The issue was found during reprocessing by a nurse.There were no reports of patient harm.

• Brand Name: GRASPING FORCEPS, 5 FR., SEMI-FLEXIBLE, STANDARD
• Common Device Name: FORCEPS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17264326
• Report Number: 9610773-2023-01806
• Device Sequence Number: 17613686
• Product Code: GCP
• UDI-Device Identifier: 04042761003483
• UDI-Public: 04042761003483
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/06/2023

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: A2500
• Device Catalogue Number: A2500
• Device Lot Number: 21X01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• 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