MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO ROTATING MCA; CLIP, IMPLANTABLE

Catalog Number ER320

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

Patient Problems Failure to Anastomose (1028); Abdominal Pain (1685); No Code Available (3191)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: unknown, assumed the (b)(6) day of month that complaint was reported.Batch # unknown.The lot / batch was not provided; therefore, the manufacturing record evaluation could not be performed.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.Was the re-op performed at the same place as the initial surgery (doctors hospital of laredo)? were there any issues noted with the device in the initial procedure? how many clips were placed on the cystic duct? if available, what is the lot number of the device? what is the color of the trigger? how was the leak identified? how was the leak addressed? were there clips visible? were they near the cystic duct? what is the current patient status?.

Event Description

It was reported by the sales rep that post-op to a laparoscopic cholecystectomy the patient presented with abdominal pain.The patient's appendix was inflamed and bile was discovered in the appendix.There were no clips on the cystic duct.It is unknown if any device is available for return.

• 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: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8926263
• MDR Text Key: 155783921
• Report Number: 3005075853-2019-21475
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012580
• UDI-Public: 10705036012580
• Combination Product (y/n): N
• PMA/PMN Number: K864102
• 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: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ER320
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2019
• 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