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

Catalog Number ERXXX

Device Problems Failure to Form Staple (2579); Device Fell (4014)

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

Event Date 09/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts are being made to obtain the following information: please confirm: what was the specific product code used on the initial procedure on (b)(6) 2019? what number of clips were used on the patient side for the cystic duct and artery? were there any clip formation issues noted at any time during the case? were there any clip formation issues noted post-op? are there any photos or images available of the clip formation? were any clips found during the post-op procedure? if so, what was the shape of the clip or clips? how was it determined that the cause of the leak was associated with clip malformation or retention? what ethicon clip appliers are available for use at this account, shenzhen jian an hospital (if product code is unavailable or is unknown)? please physically describe the clip applier used if the code if clip applier is unknown? to date no response has been provided.If the device or further details are received at a later date, a supplemental medwatch will be sent.

Event Description

This case is from health authority.It was reported that the patient was hospitalized on (b)(6) 2019 for cholecystitis and underwent laparoscopic cholecystectomy (b)(6) 2019 during which the cystic duct was ligated with a titanium clip.Abdominal pain increased on the fifth day after surgery ((b)(6)).After blood routine, crp, blood amylase, electrolyte, abdominal orthotaxis, abdominal ultrasound, and other examinations were performed, considering peritoneal effusion after cholecystectomy (physical examination: other normal).A large amount of peritoneal effusion was detected by b-mode ultrasonography, and biliary effusion was indicated by peritoneal aspiration, which was slightly relieved by corresponding anti-inflammatory therapy (physical examination: other normal).Ercp was performed in hospital on (b)(6) 2019, and bile leakage was found to be caused by titanium clip that did close and fell off.Nasal cavity drainage (abdominal drainage) was performed in hospital on (b)(6) 2019.The postoperative observation was continued on (b)(6) 2019, the b-mode ultrasound examination result was normal, no abdominal pain, and the stool returned to normal.

• 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: 9247772
• MDR Text Key: 164823582
• Report Number: 3005075853-2019-23023
• Device Sequence Number: 1
• Product Code: FZP
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ERXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR