MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SEMI-RIGID BLUNT SCISSORS WITH SINGLE ACTION JAWS, 5FR X 40CM

Model Number	26160EHW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received no further details of the event.It is possible that the broken piece was flushed out of the patient during the procedure and, therefore, nothing showed on the x-ray.The device is currently with the manufacturer for investigation.
Event or Problem Description
As per a copy of an initial mir we received from the factory in (b)(4): part of the scissors broke off in the uterine cavity.The patient was informed and then taken for x-ray and the part could not be found.
Additional Manufacturer Narrative
The device in question was sent to the manufacturing site in germany on september 7, 2020 for investigation upon evaluation, it could be confirmed that the device was not in original shape.The device shows rusty spots and the shaft is strongly bent.The movable leg is broken in the area of the riviet hole and the scissor blade is also damaged.No indication for a material or manufacturing related issue was found during the investigation.The root cause most probably is too high force application which results in tore the rivet from the leg.(b)(4).
Additional Manufacturer Narrative
Data in section h6 have been corrected to match the evaluation findings.

• Brand Name: SEMI-RIGID BLUNT SCISSORS WITH SINGLE ACTION JAWS, 5FR X 40CM
• Common Device Name: BLUNT SCISSORS
• 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, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 10532565
• Report Number: 9610617-2020-00101
• Device Sequence Number: 3578065
• Product Code: GCJ
• UDI-Device Identifier: 04048551094556
• UDI-Public: 4048551094556
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K935071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2022

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: 26160EHW
• Device Catalogue Number: 26160EHW
• Device Lot Number: RQ01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 08/28/2020; 08/10/2022
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 08/05/2022; 08/11/2022
• Date Device Manufactured: 04/01/2019
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female