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	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The broken instrument was returned for evaluation.We confirmed that the stationary jaw is broken off, the broken piece was not returned by the facility.The instrument had been in use for 16 years.Damage is most likely due to excessive force and/or handling of the device.
Event or Problem Description
Allegedly, during a laparoscopic robot assisted incarcerated incisional hernia repair procedure, at the end of the case, it was noticed the tip of the endo-closure device had fractured off inside the patient.Attempts were made with the c-arm and palpation of the abdominal wall to locate the device tip.The doctor was unable to retrieve the piece from the patient.The doctor decided to leave the tip as it was such a small object within the abdominal wall as the risk to remove was greater than the benefit.The patient was discharged the following day without further incident.

• 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: 9316578
• Report Number: 9610617-2019-00106
• Device Sequence Number: 2360871
• Product Code: GCJ
• UDI-Device Identifier: 04048551097755
• UDI-Public: 4048551097755
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K942612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/13/2019

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
• Device Lot Number: DG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 11/13/2019
• 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: 48 YR
• Patient Weight: 118