MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SUBCUTANEOUS FASCIA CLOSURE DEVICE

Model Number	26173AM
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received no further details of the event, and the device has not been returned for evaluation.The damaged/broken tip was most likely due to use of excessive force.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(4): tip broken during a laparoscopic procedure.The tip was retrieved through a slightly increased incision.
Additional Manufacturer Narrative
The case was recorded twice the customer had given an incorrect article number when reporting directly to our company so this was not noticed.The bfarm has recorded the other case under (b)(4)the complete final report is made under this number.
Additional Manufacturer Narrative
Due to doublicate information this case is proceeded further.Complete documentation will be done in (b)(4).

• Brand Name: SUBCUTANEOUS FASCIA CLOSURE DEVICE
• Common Device Name: SUBCUTANEOUS FASCIA CLOSURE DEVICE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, 78532 ; GM 78532
• 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 ; 4242188201
• MDR Report Key: 10525521
• Report Number: 9610617-2020-00097
• Device Sequence Number: 11549288
• Product Code: GCJ
• UDI-Device Identifier: 04048551097755
• UDI-Public: 4048551097755
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K942612
• 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): 08/01/2023

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: 26173AM
• Device Catalogue Number: 26173AM
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 08/25/2020; 08/25/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 08/05/2022; 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown