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

Model Number ER320

Device Problem Failure to Form Staple (2579)

Patient Problems Peritonitis (2252); Not Applicable (3189); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # t93l0j.Investigation summary the analysis results found that the er320 device was returned with no damage in the external components and with a clip in the jaws.The clip was removed in order to inspect the jaws and they were found with no damage.In an attempt to replicate the reported incident, the device was tested for functionality.During the analysis, the device was cycled and it fed, retained, and formed the remaining 9 clips as intended.The event described could not be confirmed as the device performed without any difficulties noted.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Event Description

It was reported that during an unknown procedure, the laparoscopic clip applicator did not close well.The cystic duct was closed with 3 clips,one up and two low.The clips only closed in the "lips," not in the middle.The patient had problems after surgery, had biliary peritonitis, and needed a laparotomy and a stay in the intensive care.

Manufacturer Narrative

(b)(4).Date sent: (b)(6)2020.H2: additional information: attempts have been made to obtain the following information: was clip malformation immediately identified during initial surgery? what is surgeon¿s experience with this device? was there any torqueing or downward pressure during clip application? what was done to address the malformed clips intraoperatively? were clips found on structures during 2nd procedure? if so, please describe the shape of the clips.Are there any photos or videos available from the procedures (initial procedure and/or reoperation)? what is the current patient status? the following additional information was received: in this surgery it was possible to observe the cause of biliary peritonitis.It was due to the clips applied, to lacquer the cystic canal, not closing in the middle, just in the tip, leaving the middle not closed, motivating the escape of bile and consequent peritonitis.If further details are received at a later date, a supplemental medwatch will be sent.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9848608
• MDR Text Key: 190636976
• Report Number: 3005075853-2020-01685
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ER320
• Device Catalogue Number: ER320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Date Manufacturer Received: 04/07/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention