MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FASCIAL CLOSURE INSTRUMENT, 2.8MM, 17CM

Model Number	26173AM
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the product was found defect out of the box.An internal assessment revealed that the jaw part is broken.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device in question was returned manufacturer on april 3, 2025.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: the customer's description can be confirmed.The connecting rivet in the jaw has been sheared off.The most probable root cause of this is excessive force (e.G., gripping objects not intended for this purpose or squeezing too tightly) on the jaw.Based on the pressure marks in the mouthpiece, it can be concluded that the instrument has been used at least once, so it cannot be an out-of-box failure.The above conducted investigations did not reveal a root cause related to the labelling, the device or its history.All production related quality checks were passed and no non-conformities were identified in the devices manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pick up in similar complaints, no trend was identified.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: FASCIAL CLOSURE INSTRUMENT, 2.8MM, 17CM
• Common Device Name: FASCIAL CLOSURE INSTRUMENT, 2.8MM, 17CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 21915117
• Report Number: 9610617-2025-00703
• Device Sequence Number: 21038094
• Product Code: GCJ
• UDI-Device Identifier: 04048551097755
• UDI-Public: 04048551097755
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

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: ZL05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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