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

Catalog Number EL5ML

Device Problems Misfire (2532); Failure to Form Staple (2579)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.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.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.

Event Description

It was reported that during a lap hernia repair, the surgeon went to use a clip applier and it misfired.The only explanation is that the device clips did not clamp together on multiple tries.This caused them to use another clip applier which did the same thing.This cycle happened 3 times and then the fourth applier worked.No patient issues.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9528348
• MDR Text Key: 191852720
• Report Number: 3005075853-2019-24785
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• Combination Product (y/n): N
• 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
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EL5ML
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1