MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIOPSY AND GRASPING FORCEPS; GYNAECOLOGICAL BIOPSY FORCEPS

Model Number	26160UHW
Medical Device Problem Codes	Break (1069); Material Erosion (1214)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(4): the event occurred in (b)(6).It was reported that tweezers and scissors that are part of the new hysteroscopy kits, are leaving metal fragments in the surgical process, that is, in the uterine cavity.No harm to patient reported.((b)(4)).
Additional Manufacturer Narrative
The initial information received did not report any adverse effects on the patient.Further information was already requested but not yet received.The affected unit was returned, but the investigation is pending.
Additional Manufacturer Narrative
Upon examination of the returned products (2 x 26160uhw and 2 x 26160ehw), no loss or abrasion of components could be found.The products were found to be complete.It is not possible to confirm that the particle that remained in the patient's body was a result of the karl storz products used.During the examination, the described fault of the customer could not be confirmed, as there is no wear and tear on the instruments.The affected instruments are bent, indicating that too much force was applied.Furthermore, the instruments show rust deposits, which can also be seen on the intraoperatively taken pictures.No injury to the patient, user or third, and no post-op harm was reported.

• Brand Name: BIOPSY AND GRASPING FORCEPS
• Common Device Name: GYNAECOLOGICAL BIOPSY FORCEPS
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 12778896
• Report Number: 9610617-2021-00072
• Device Sequence Number: 3547936
• Product Code: GCJ
• UDI-Device Identifier: 04048551094679
• UDI-Public: 4048551094679
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K934937
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021

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: 26160UHW
• Device Catalogue Number: 26160UHW
• Device Lot Number: UO01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown