MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, SHARK TEETH, 5 FR., SEMIFLEXIBLE; HAND INSTRUMENTS, STANDARD (WITHOUT CURRENT)

Model Number	A4825
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Fragmentation (1261); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Event or Problem Description
Olympus was informed that during an unspecified uterus examination, when the surgeon removed the hysteroscope, he noticed that one jaw at the distal end of the grasping forceps was broken off and missing.He inserted the hysteroscope back into the uterus to check if the fragment was there but it could not be located.An x-ray examination was performed but the fragment still could not be located and it was assumed that it was flushed out with the irrigation fluid.The intended procedure was completed using the same set of equipment and there was no report about an adverse event or patient injury.
Additional Manufacturer Narrative
The suspect medical device was not returned to the manufacturer for evaluation/investigation since it was reportedly discarded by the user facility.Therefore, the exact cause of the user¿s experience and the reported phenomenon could not be conclusively determined and is being judged as unknown.A dhr review could not be performed since basic data of article identification (lot number) is missing.Instead, a manufacturing and quality control review was performed for the last 24 months of production.There were no non-conformities or deviations regarding the described issue.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: GRASPING FORCEPS, SHARK TEETH, 5 FR., SEMIFLEXIBLE
• Common Device Name: HAND INSTRUMENTS, STANDARD (WITHOUT CURRENT)
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): DAUSCH MEDIZINTECHNIK GMBH; daimlerstrasse 13; wurmlingen
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 12466026
• Report Number: 9610773-2021-00253
• Device Sequence Number: 14675629
• Product Code: NWW
• UDI-Device Identifier: 04042761006880
• UDI-Public: 04042761006880
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: 510(K)EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2022

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: A4825
• Device Catalogue Number: A4825
• Device Lot Number: UNKNOWN
• 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: 09/09/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 01/19/2022
• 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: Female