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

Model Number	26173AM
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a case the tip of the device broke off into the patient.The incision was enlarged to search for and remove the broken piece from patient's abdominal tissue.Patient was under a prolong anesthesia due to additional removing broken piece procedure and x-rays confirmation as the end of the procedure.The tip was discarded as it was removed from inside the patient.The procedure was prolonged by 45 to 60 minutes.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
The device was returned to our us facility on may 01, 2025.It 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 id: (b)(4).
Additional Manufacturer Narrative
Per investigation by the manufacturing site: there are signs of corrosion (crevice corrosion/pitting corrosion).In combination with excessive force (e.G., gripping objects not intended for this purpose or squeezing too tightly) on the jaw and the visible corrosion, this has led to the breakage.Due to the age of the article and the assumed number of reprocessings, this may also have affected the material properties.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.This event is filed under internal 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, 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: 21921858
• Report Number: 9610617-2025-00708
• Device Sequence Number: 18321630
• Product Code: GCJ
• UDI-Device Identifier: 04048551097755
• UDI-Public: 04048551097755
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 07/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26173AM
• Device Catalogue Number: 26173AM
• Device Lot Number: UN04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 05/01/2025; 07/21/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/08/2025; 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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; Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 73 KG