MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGAMAX 5MM; CLIP, IMPLANTABLE

Catalog Number EL5ML

Device Problem Bent (1059)

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

Event Date 02/21/2014

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, repeatedly tried to deploy clips and they were coming out already bent.They pulled clippers/clips out of abdomen and dislodged clip.They tried again and had the same problem.A second device was opened and the case was completed with no patient consequences.

Manufacturer Narrative

(b)(4): information is unavailable.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.At the time of this submission, the device has not been returned for analysis.

Manufacturer Narrative

(b)(4).The analysis results found that the el5ml device was returned in good visual condition.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, the device was cycled, fed, and formed the remaining 5 clips as intended.In order to confirm the clips were within manufacturing specifications, the clips were evaluated using a tool that is designed to determine proper formation.During analysis the jaws opened and closed as intended.In addition the device locked out as intended.No conclusion could be reached as to what may have caused the reported incident.A batch/lot record review was performed and the batch met all final acceptance criteria.

• Brand Name: LIGAMAX 5MM
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3702149
• MDR Text Key: 4230143
• Report Number: 3005075853-2014-01957
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2014

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 Expiration Date: 12/29/2018
• Device Catalogue Number: EL5ML
• Device Lot Number: L4E514
• Other Device ID Number: BATCH # UNK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/10/2014
• Initial Date FDA Received: 03/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1