MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, OPTICAL, FOR 12° AND 30° TELESCOPE; RIGID ENDOSCOPIC GRASPING FORCEPS, REUSABLE

Model Number	A20718A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned for evaluation.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
Customer reported that his instrument broke.According to the report, the device broke during an unspecified procedure.According to the reporter, the doctor was able to retrieve all the shards (broken pieces) and there was no harm.There was no patient harm, no user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved 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, and since the device was not returned for evaluation, the definitive root cause of the broken device could not be determined.The broken damage was most likely caused by wear and tear in accordance with the age of the device, frequent use, or excessive force.Olympus will continue to monitor field performance for this device.

• Brand Name: GRASPING FORCEPS, OPTICAL, FOR 12° AND 30° TELESCOPE
• Common Device Name: RIGID ENDOSCOPIC GRASPING FORCEPS, REUSABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 15211257
• Report Number: 9610773-2022-00327
• Device Sequence Number: 17293552
• Product Code: GCP
• UDI-Device Identifier: 04042761029889
• UDI-Public: 04042761029889
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2022

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: A20718A
• Device Catalogue Number: A20718A
• Device Lot Number: 168W-0003
• 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: 07/14/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• 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