MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY SUBCUTANEOUS FASCIA CLOSURE

Model Number	26173AM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument was evaluated and 1 jaw was broken off and the shaft is bent.Possible cause was stress overload, but we cannot confirm.
Event or Problem Description
Allegedly, the doctor was performing a lap appendectomy when a jaw broke off instrument into patient.They used a c-arm to locate the broken piece and the doctor removed it.There was a 30 minute delay which caused no injury to the patient.He went on to complete procedure.The hospital reports there was no injury to the patient.

• Brand Name: SUBCUTANEOUS FASCIA CLOSURE
• Common Device Name: SUBCUTANEOUS FASCIA CLOSURE
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• MDR Report Key: 6616856
• Report Number: 9610617-2017-00040
• Device Sequence Number: 623878
• Product Code: GCJ
• UDI-Device Identifier: 04048551097755
• UDI-Public: 4048551097755
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K954011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2017

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
• Device Lot Number: WU
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2017
• Initial Report FDA Received Date: 06/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 86