MAUDE Adverse Event Report: KARL STORZ SE & CO. KG DEVICE, SUBCUANEOUS FACIA CLOSURE; BERCI FASCIAL CLOSURE DEVICE

Model Number	26173AM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product has not been returned, therefore no evaluation findings are available, should additional information be available a supplemental filing maybe submitted.
Event or Problem Description
During a laparoscopic vertical or partial gastrectomy procedure, the tip of the instrument broke in the fatty layers of the patient.Attempts were made with ultrasound and palpations to locate the device tip.The doctor was unable to retrieve the piece from the patient.The doctor decided to leave the tip inside and informed the patient.An x-ray was taken in recovery which was also negative.

• Brand Name: DEVICE, SUBCUANEOUS FACIA CLOSURE
• Common Device Name: BERCI FASCIAL CLOSURE DEVICE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm
• MDR Report Key: 11611040
• Report Number: 9610617-2021-00037
• Device Sequence Number: 19604525
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 04/02/2021
• 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: Required Intervention
• Patient Age: 37 YR
• Patient Weight: 91