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

Catalog Number EL5ML

Device Problems Bent (1059); Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a laparoscopic cholecystectomy, the device wasn't firing and it appears that the right jaw is bent.The procedure was completed using a like device.No additional information was available.

Manufacturer Narrative

(b)(4).Batch # n90w2p.The analysis results found that the el5ml device was received with one jaw disengaged from the cam; this condition would not allow the jaws to collapse in order to form the clips.In order to evaluate the performance of the device, the jaw was readjusted and in the next actuations, 4 conforming clips were fed and formed; finally the device locked out as intended.Possible causes for the condition of the jaw disengaged from the cam may be inadvertent force, twisting or pressure being placed on the device jaws, using the jaws of the device as a dissector/retractor or damage to the jaws while entering the trocar; however, no conclusion could be reached as to what may have caused this condition.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Brand Name: LIGAMAX 5MM
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5799583
• MDR Text Key: 50388492
• Report Number: 3005075853-2016-03999
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2016

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: 02/28/2021
• Device Catalogue Number: EL5ML
• Device Lot Number: N4LA9X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/20/2016
• Initial Date FDA Received: 07/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1