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

Model Number	26173AM
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufactors complaint reference is (b)(4).Per the facility, the device was loaded properly, however when dr.Inserted the device into the abdomen, under laparoscopic guidance, the bottom-pointed tip of the endoclose device broke off inside the patient into the abdomen.The piece was retrieved using laparoscopic graspers and management was notified.No information of harm to patient, user or third was provided.
Additional Manufacturer Narrative
Product has not been returned, therefore no evaluation findings are available, should additional information be available a supplemental filing maybe submitted.The ifu pi-000052 ifu v6.0 states "inspect the instrument for cleanliness and damage.Do not use instruments that show visible signs of damage or that are difficult to use.Any malfunction of an instrument during a procedure could result in injury to the patient and further damage to the instrument.".

• 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
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 15562325
• Report Number: 9610617-2022-00277
• Device Sequence Number: 5862249
• Product Code: GCJ
• UDI-Device Identifier: 04048551097755
• UDI-Public: 4048551097755
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2022

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: 09/07/2022
• Initial Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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