MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FASCIAL CLOSURE INSTRUMENT

Model Number	26173AM
Medical Device Problem Codes	Break (1069); Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint (b)(4).
Event or Problem Description
It was reported during a medical procedure on (b)(6) 2024, the fascial closure instrument tip broken/missing.The surgon found it inside of the subcutaneus fat and gently returieved it using a halsted clamp.The surgery went well with no other complications mentioned.
Additional Manufacturer Narrative
Per investigation by the manufacturing site: based on the customer's description, the mouthpiece of the suture instrument is damaged/broken.The most probable root cause of this is overloading of the joint/its components.Due to the age of the article (dec.2012) and the assumed number of times it has been reprocessed, this may also have had a negative impact on the material properties.This event is filed under internal complaint id (b)(4).

• Brand Name: FASCIAL CLOSURE INSTRUMENT
• Common Device Name: FASCIAL CLOSURE INSTRUMENT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 20247075
• Report Number: 9610617-2024-00253
• Device Sequence Number: 20653696
• Product Code: GCJ
• UDI-Device Identifier: 04048551097755
• UDI-Public: 04048551097755
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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
• Device Lot Number: ZX02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 07/17/2025
• 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
• Patient Sex: Unknown