MAUDE Adverse Event Report: ETHICON ENDO-SURGERY INC. LIGACLIP 12-L; APPLIER, SURGICAL, CLIP

Lot Number R93U8R

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2018

Event Type  malfunction  

Event Description

Patient underwent laparoscopic cholecystectomy and repair of umbilical hernia.During procedure it was noted that the endoclip did not operate correctly on two different occasions.It was removed from sterile field, new endoclip obtained which operated without incident.

• Brand Name: LIGACLIP 12-L
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): ETHICON ENDO-SURGERY INC.
• MDR Report Key: 7926189
• MDR Text Key: 122629538
• Report Number: MW5080266
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/28/2018

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
• Device Operator: Health Professional
• Device Lot Number: R93U8R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2018
• 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 Age: 47 YR