MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. LIGAMAX; CLIP, IMPLANTABLE

Model Number EL5ML

Device Problems Bent (1059); Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2016

Event Type  malfunction  

Event Description

During laparoscopic cholecystectomy, the surgeon attempted to use the clip applier when he noticed that the staples were bent and the device would not work.There was no patient harm.

• Brand Name: LIGAMAX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 4545 creek rd.; ml 120a; cincinnati OH 45242
• MDR Report Key: 6431905
• MDR Text Key: 70793522
• Report Number: 6431905
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/15/2017,02/22/2017

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
• Device Operator: No Information
• Device Model Number: EL5ML
• Device Catalogue Number: EL5ML
• Device Lot Number: P00019P67
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/15/2017
• Event Location: Other
• Date Report to Manufacturer: 02/15/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR