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

Model Number	IPN923663
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The sample investigation is pending.Teleflex will continue to monitor and trend related events.
Event or Problem Description
The product was used during a gastric sleeve procedure on the patient when a small portion of the suture holder, the arrow/tab broke off.The doctor removed the shield and retrieved the broken portion.A second product was used to successfully close the fascia.No patient injury or adverse effect.Additional information identified a part of the suture wing as the part that broke.It was retrieved.
Event or Problem Description
The product was used during a gastric sleeve procedure on the patient when a small portion of the suture holder, the arrow/tab broke off.The doctor removed the shield and retrieved the broken portion.A second product was used to successfully close the fascia.No patient injury or adverse effect.Additional information identified a part of the suture wing as the part that broke.It was retrieved.
Additional Manufacturer Narrative
Qn#(b)(4).A review of the dhr could not be performed as no lot number was provided.A review of the returned unit shows that the device was bent, indicating that it was mishandled / used in an unintentional manner.The tab was also confirmed to be cracked.However, as the device was misused, the cause of the cracked tab cannot be assessed.Given the condition of the device in which it was returned, paragon medical can verify that the device is non-functional, but the source of the issue cannot be verified.Therefore, this complaint is considered verified but not valid.

• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15550382
• Report Number: 3011137372-2022-00189
• Device Sequence Number: 6158622
• Product Code: HCF
• UDI-Device Identifier: 14026704739001
• UDI-Public: 14026704739001
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2022

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: IPN923663
• Device Catalogue Number: EFX002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male