MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC LIGACLIP; APPLIER, SURGICAL, CLIP

Model Number MCM20

Device Problem Misfire (2532)

Patient Problem Laceration(s) (1946)

Event Date 04/26/2019

Event Type  Injury  

Event Description

Misfired stapler.Clip applier.Ethicon.Ref # (b)(4).The surgeon used this 4-5 times without any problem.A misfire occurred and it severed the vessel.The stapler was fired again and it clipped the vessel.No less than 5 unnamed, large veins were identified and ligated.The facial vein was one of the vessels which was ligated in this area.The facial vein was ligated at its takeoff point from the internal jugular vein.Several medium clips were placed across this area and a stick tie was also placed underneath the clips to ensure hemostasis.

• Brand Name: LIGACLIP
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 4545 creek rd.; cincinnati OH 45242
• MDR Report Key: 8658020
• MDR Text Key: 146641474
• Report Number: 8658020
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002475
• UDI-Public: (01)10705036002475(17)240131(10)T4046A
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCM20
• Device Catalogue Number: MCM20
• Device Lot Number: T4046A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 10585 DA
• Patient Weight: 81