MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK AUTO ENDO 5; HEM-O-LOK

Model Number 543965

Device Problem Difficult to Remove (1528)

Patient Problem Laceration(s) (1946)

Event Date 03/03/2017

Event Type  Injury  

Event Description

Weck hem-o-lok auto endo 5 clamped but device would not release from pt's tissue.Add'l clamps had to be placed around this device to allow it to be dissected away from the pt.The surgical procedure had to be converted to open requiring a stay in the hospital.Reason for use: cholecystitis.

• Brand Name: WECK AUTO ENDO 5
• Type of Device: HEM-O-LOK
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC 27709
• MDR Report Key: 6383784
• MDR Text Key: 69376989
• Report Number: MW5068302
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 04026704600885
• UDI-Public: 0104026704600885
• 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: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2019
• Device Model Number: 543965
• Device Lot Number: 73F1600565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• 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): Hospitalization
• Patient Age: 49 YR
• Patient Weight: 108