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

Catalog Number EL5ML

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Just for clarification, when the "jaw of the hand does not return after clipping", did the jaws of the device not open after the device had been fired? was the device stuck on tissue or a vessel when it would not open? if yes, how was the device removed? were the device jaws eventually able to be opened?.

Event Description

It was reported that during an unknown procedure, the jaw of hand does not return after clipping.Another like device was used to complete the procedure.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: just for clarification, when the "jaw of the hand does not return after clipping", did the jaws of the device not open after the device had been fired? was the device stuck on tissue or a vessel when it would not open? if yes, how was the device removed? were the device jaws eventually able to be opened? response received: after clipping, i did know what it happened.But it did not working at all anyway.No stucking on tissue as nurse said.

Manufacturer Narrative

(b)(4).Batch # p91a7f.The analysis results of the el5ml found that the device was received with one jaw broken at bifurcation.The device was disassembled and evidence of corrosion was found throughout the broken area.2 remaining clips were found on the clip track.The most likely reason for jaw bifurcation breakage is stress corrosion cracking and the most likely root cause is exposure to a solution containing chlorine.In addition, in order to avoid this kind of issues please do not reuse, reprocess or re sterilize device.Reuse, reprocessing or re sterilization may compromise the structural integrity of the device and/or lead to device failure that in turn may result in patient injury, illness or death.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 ENDO CLIP APPLIER
• 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: 6725194
• MDR Text Key: 80656192
• Report Number: 3005075853-2017-03707
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2021
• Device Catalogue Number: EL5ML
• Device Lot Number: P4R147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2017
• 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