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)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while closing the trocar site during a laparoscopic sleeve gastrectomy, the jaw of the berci needle broke off of the instrument and became stuck in the subcutaneous tissue.Surgery was stopped and x-ray was called in with a portable machine.The broken piece was located under fluoroscopy and removed from the subcutaneous tissue.After surgery, and before leaving the room, an additional x-ray was taken and read- the x-ray was determined to be clear without any retained objects.The broken item will be taken to risk management for further evaluation.Soft tissue injury to abdomen.Customer support will continue to follow the instruction for use- surgeon states that during this procedure he was trying to go through mesh.There's a possibility the distal tip of the berci caught the mesh and with pressure applied may have caused the issue.Temporary harm-minimal.Device failed (e.G.Broke, couldn't get it to work or stopped working); device malfunction- that is, the device did not do what it was supposed to do.
Additional Manufacturer Narrative
The previous reportability decision for this event was reversed based on a retrospective review.The complaints describe issues with 26173am (device,subcutaneous fascia closure).Tt was reported that pieces of the device broke off during a procedure.In both cases, additional medical intervention (x-ray, fluoroscopy) was necessary to locate and retrieve the pieces.In one case a soft tissue injury was reported.A complaint history review (from the last two years (b)(6) 2021 - (b)(6) 2023) yielded two com-plaints that describe similar malfunction (tip broke off while closing wound; endoclose device broke off inside the pt) of the device 26173am that have been filed as mdr no negative impact on the state of health had been reported, but the incidents were determined to be reportable due to a similar case in which the tip of the device remained in the patient.Thus, also for the complaints under consideration, the malfunction of pieces breaking off should be evaluated as having the potential, if it recurs, to contribute to or cause a serious injury.The product has not been returned.The facility received the product on multiple outbounds from 2017 to 2021.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
• 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
• MDR Report Key: 17402025
• Report Number: 9610617-2023-00186
• Device Sequence Number: 7493795
• Product Code: GCJ
• UDI-Device Identifier: 04048551097755
• UDI-Public: 4048551097755
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2023

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
• 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: 07/26/2023
• Initial Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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