MAUDE Adverse Event Report: TELEFLEX MEDICAL HORIZON TI ML 6/CART 120/BOX; CLIP, IMPLANTABLE

Catalog Number	003200
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that the "patient underwent cholecystectomy procedure with cholangiography by videolaparoscopy, but after going to the unit, he continued with severe abdominal pain, distension, nausea and vomiting.The patient made a thomography scan of the abdomen and it was identified that the clips had a small amount of free liquid, next to the emptied bed, in the abdominal cavity and notably in the pelvic region, as well as obliteration of adjacent fat, related to previous manipulation.There was a need for surgical reapproach to which it was identified that the clip was open".At the time of this report the customer has not returned our requests or additional information.If additional information is received, the complaint file will be updated.

• Brand Name: HORIZON TI ML 6/CART 120/BOX
• Common Device Name: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17481657
• Report Number: 3003898360-2023-01173
• Device Sequence Number: 6983045
• Product Code: FZP
• UDI-Device Identifier: 24026704696370
• UDI-Public: 24026704696370
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K132658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2023

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 Catalogue Number: 003200
• Device Lot Number: 73F2200970
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown