MAUDE Adverse Event Report: TELEFLEX WECK HEM-O-LOCK

Lot Number 73A1700205

Device Problems Break (1069); Detachment Of Device Component (1104); Defective Component (2292); Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2017

Event Type  Injury  

Event Description

Patient having laparoscopic cholecystectomy.During procedure, it was noted that the disposable weck hem-o-lock device had malfunctioned.Surgeon found the tip to be loose and it broke off in his hand.Second hem-o-lock was opened and found to be defective also - the clip would not open fully when it was engaged in the instrument.No harm to the patient.

• Brand Name: WECK HEM-O-LOCK
• Type of Device: WECK HEM-O-LOCK
• Manufacturer (Section D): TELEFLEX; morrisville NC 27560
• MDR Report Key: 6380648
• MDR Text Key: 69252702
• Report Number: MW5068274
• Device Sequence Number: 1
• Product Code: HBQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/02/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 73A1700205
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 MO