MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK L CLIPS 6/CART 84/BOX; CATHETER, UROLOGICAL

Catalog Number 544240

Device Problem Use of Device Problem (1670)

Patient Problem Perforation of Vessels (2135)

Event Date 05/01/2022

Event Type  Injury  

Event Description

Reported from the published abstract of the 36th congress of japanese society for endoscopic surgery, "renal artery injury occurred when the renal artery was clipped with hem-o-lok clips early after rarn began to be performed" additional information received from the doctor states "in the md's opinion, renal artery injury was not caused by hem-o-lok clip, but because that the assistant doctor approached to the artery with too much force.There was no causal relationship between the clip and bleeding".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

Manufacturer Narrative

(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.

• Brand Name: HEMOLOK L CLIPS 6/CART 84/BOX
• Type of Device: CATHETER, UROLOGICAL
• 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: 18393348
• MDR Text Key: 331316127
• Report Number: 3003898360-2023-01634
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544240
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1