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

Model Number	543965
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/03/2017
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: HEM-O-LOK
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC 27709
• MDR Report Key: 6383784
• Report Number: MW5068302
• Device Sequence Number: 13566707
• Product Code: GDO
• UDI-Device Identifier: 04026704600885
• UDI-Public: 0104026704600885
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2017

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 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 49 YR
• Patient Weight: 108