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

Model Number 26173AM

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2023

Event Type  malfunction  

Event 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.

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.".

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
• Type of Device: 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
• MDR Text Key: 313427885
• Report Number: 9610617-2023-00069
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04048551097755
• UDI-Public: 4048551097755
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 73 KG