MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK EFX SHIELD PORT SITE CLOSURE SYSTEM; INSTRUMENT, LIGATURE PASSING A

Model Number	IPN914218
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.
Event or Problem Description
The fascial closure system is broken during use in bariatric surgery.
Event or Problem Description
The fascial closure system is broken during use in bariatric surgery.
Additional Manufacturer Narrative
(b)(4).An evaluation of the returned unit along with the pictures received confirmed the failure mode observed by the customer.A review of the dhr for the lot number provided was performed and there were no manufacturing abnormalities observed.It should be noted that 100% of all devices manufactured go through testing for the approximation wing hinge integrity and both sides must pass for the device to be considered acceptable.Devices that do not pass both sides are rejected.Additionally, all subsequent functional testing would not have been able to be performed.Since the devices receive 100% in-line testing for both hinge integrity and functional performance, the complaint is considered verified, but not a paragon medical failure.
Additional Manufacturer Narrative
(b)(4).An evaluation of the stated complaint could not be performed as no device is available for return.A review of the dhr for the lot number provided was performed and there were no manufacturing abnormalities observed.A review of the images provided by the customer showed that the device was in fact damaged.It should be noted that 100% of all devices manufactured go through testing for the approximation wing hinge integrity and both sides must pass for the device to be considered acceptable.Devices that do not pass both sides are rejected.Additionally, all subsequent functional testing would not have been able to be performed.Since the devices receive 100% in-line testing for both hinge integrity and functional performance, the complaint is considered verified, but not a paragon medical failure.
Event or Problem Description
The fascial closure system is broken during use in bariatric surgery.

• Brand Name: WECK EFX SHIELD PORT SITE CLOSURE SYSTEM
• Common Device Name: INSTRUMENT, LIGATURE PASSING A
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13957156
• Report Number: 3011137372-2022-00055
• Device Sequence Number: 19880371
• Product Code: HCF
• UDI-Device Identifier: 14026704739001
• UDI-Public: 14026704739001
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/22/2022

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: IPN914218
• Device Catalogue Number: EFX002
• Device Lot Number: 3348210000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 05/20/2022; 05/20/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 05/21/2022; 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown