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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was event with a 26173am a fascial closure instrument 2.8mm, 17cm.According to the information received via the medwatch report 0501290000-2023-8001 and the facility, during a laparoscopic appendectomy procedure, at closing the closure device broke outside of the patient on the sterile field.Per the facility no patient harm and procedure was completed.
Additional Manufacturer Narrative
Manufacturing site evaluation: the instrument evidence of use: the bottom jaw was broken off and the outer tension rod was found on the front of closure handle instead of the rear.In addition, the shaft was found to be bent.The event is filed under internal karl storz complaint id (b)(4).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.".
Additional Manufacturer Narrative
Manufacturing site evaluation: the fracture of the jaw is due to overstressing.The high age (nov.2013) of the product and the associated reconditioning cycles may have favored this damage pattern.The event is filed under internal karl storz complaint id (b)(4).

• 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: 16664408
• Report Number: 9610617-2023-00069
• Device Sequence Number: 17772541
• Product Code: GCJ
• UDI-Device Identifier: 04048551097755
• UDI-Public: 4048551097755
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2023

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: YW01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2013
• 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 Age: 33 YR
• Patient Sex: Female
• Patient Weight: 73 KG