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

Lot Number M4HXO6

Device Problems Bent (1059); Failure to Form Staple (2579)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2015

Event Type  malfunction  

Event Description

During laparoscopic sleeve gastrectomy, physician used the ligamax clip applier and noticed the staples were bent/crooked when applied to patient.Staples were removed from patient and new set opened.No patient harm.

• Brand Name: LIGAMAX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO SURGERY, INC.; 4545 creek road; cincinnati, OH 45242
• MDR Report Key: 5292438
• MDR Text Key: 33358513
• Report Number: 5292438
• 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: 12/07/2015

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?: No
• Device Operator: Physician
• Device Lot Number: M4HXO6
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/07/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR