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

Catalog Number EL5ML

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure to Anastomose (1028); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: unknown.Batch # unknown.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.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.Were there any difficulties with the device intra-op? if yes, please explain.How many clips were placed on the specimen side? how many clips were placed on the patient side? were there any clip formation issues intra-op or post-op? is it the surgeon¿s normal routine to load the clip off vessel and inspect the jaw tips to ensure the clip is fully advanced prior to deployment? what is the current patient status?.

Event Description

It was reported, laparoscopic cholecystectomy: product deployed normal during procedure, patient represented with ongoing pain, exploratory laparoscopy performed on (b)(6) 2019 which found bile leakage from cystic duct, patient underwent subsequent procedure to rectify.

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was obtained: were there any difficulties with the device intra-op? no.How many clips were placed on the specimen side? 1 clip.How many clips were placed on the patient side? 2 clips.Were there any clip formation issues intra-op or post-op? none.Is it the surgeon¿s normal routine to load the clip off vessel and inspect the jaw tips to ensure the clip is fully advanced prior to deployment? yes.What is the current patient status? patient is well now, but required additional procedures resulting from bile leakage.

Manufacturer Narrative

(b)(4).Per photographic evidence: upon visual inspection of two photos, the following was observed: the photos show tissue from top view and slightly bleeding was noted.Based on the photos reviewed, the event describe is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Additional information was received that the device was discarded.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8883612
• MDR Text Key: 153979518
• Report Number: 3005075853-2019-21179
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EL5ML
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/19/2019
• Patient Sequence Number: 1