MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SUBCUTANEOUS FASCIA CLOSURE DEVICE

Model Number	26173AM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not yet received the item for evaluation.
Event or Problem Description
Allegedly, the tip of the instrument broke off in the patient during a procedure.X-ray was done afterwards and the broken tip was found lodged in the patient's abdominal tissue.The piece was not retrieved and hospital states the surgeon disclosed this to the patient.
Additional Manufacturer Narrative
We evaluated the instrument.The fixed jaw is missing (clean break), the shaft is bent, and there are scratch marks on distal end of the shaft.Breakage is most likely due to stress overload.

• Brand Name: SUBCUTANEOUS FASCIA CLOSURE DEVICE
• Common Device Name: SUBCUTANEOUS FASCIA CLOSURE DEVICE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 6989076
• Report Number: 9610617-2017-00089
• Device Sequence Number: 16168505
• Product Code: GCJ
• UDI-Device Identifier: 04048551097755
• UDI-Public: 4048551097755
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K942612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2017

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: Physician
• Device Model Number: 26173AM
• Device Catalogue Number: 26173AM
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/02/2017
• Supplement Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 10/30/2017
• Supplement Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other