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

Model Number	26173AM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.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).
Event or Problem Description
It was reported that shaft is broken.No negative impact in state of patient health reported.
Additional Manufacturer Narrative
New information was received march 25, 2025 and march 26, 2025.The event description was corrected as follows: the defect was detected during incoming inspection at the customer.The instrument was defective out of the box.Tip unhooked.The instrument was not used.There was no patient or procedure involved.According to the event description there is no information that the event caused a harm or serious injury to patient, user or third party.Since the risk analysis is based to patient, user or third party harms no risk-id is applicable to the reported event.Non-serious events are monitored through the trending process (q1.5.0001.Wi002).Based on this new information the sentinel event referenced in version ba is not applicable and no similar event that caused or contributed to a death or serious injury could be found.In conclusion the probability of this malfunction to cause or contribute to a death or serious injury is considered as negligible and therefore not reportable.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
An incorrect address was provided in section g1 in the initial report.This supplemental report is to provide the correct contact information for this section.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Adding awareness date for 9610617-2025-00284 supplemental #2, as it was submitted without the awareness date.The awareness date should be april 14, 2025.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 ; 4242188247
• MDR Report Key: 21462419
• Report Number: 9610617-2025-00284
• Device Sequence Number: 7764170
• Product Code: GCJ
• UDI-Device Identifier: 04048551097755
• UDI-Public: 04048551097755
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/15/2025

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: WL05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 04/01/2025; Not provided; 04/14/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 04/03/2025; 04/14/2025; 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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