MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE FORCEPS INSERT; LAPAROSCOPIC FORCEPS

Model Number	33310ON
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the factory for evaluation.
Event or Problem Description
As per a copy of a mir we received from the factory in (b)(6): the instrument has been used to mobilize the uterine graft.At the end of the operation, a millimeter piece of the distal branch of the forceps is missing, confirmed with control x-ray.The patient was informed.
Additional Manufacturer Narrative
Data in section h6 have been corrected to match the evaluation findings.

• Brand Name: CLICKLINE FORCEPS INSERT
• Common Device Name: LAPAROSCOPIC 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, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 11151514
• Report Number: 9610617-2021-00002
• Device Sequence Number: 3920297
• Product Code: GCJ
• UDI-Device Identifier: 04048551134580
• UDI-Public: 4048551134580
• 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): 08/15/2022

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: 33310ON
• Device Catalogue Number: 33310ON
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 12/21/2020; 08/15/2022
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 01/13/2021; 08/15/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female