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

Catalog Number ER420

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.Attempts are being made to obtain the following information and device: how much bleeding occurred? how was the bleeding controlled? did the patient receive any blood products? if yes: how much blood products did the patient receive? was there any change to the procedure as a result of the bleeding that occurred during surgery? was there any change to post-op care of patient as a result of bleeding that occurred during surgery? what is the patients current condition? 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

It was reported that during a laparoscopic cholecystectomy, clips were attached to a.Cystica, cysticus.The clips loosened intraoperatively and the result was heavy bleeding.It is unknown how procedure was completed and patient outcome is unknown.

Manufacturer Narrative

(b)(4).Batch # t93d6l.Investigation summary: the analysis results found that the er420 device was returned inside of its sterile packaging and with no damage in the external components.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 20 clips as intended.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, no anomalies were found.As the device was found to be fully functional, it could not be determined what may have caused the reported incident.No conclusion could be reached as to what may have caused the reported incident.The reported complaint could not be confirmed.

Manufacturer Narrative

(b)(4).Batch # t93d6l.Concomitant medical products: date device returned to manufacturer is 11/11/2019 (the device used in the procedure was returned instead of the unopened sterile sample that was previously returned and reported on).If follow-up what type: device evaluation was performed on the actual device that was used in the procedure instead of the unopened sterile sample that was previously returned and reported on (see investigation below of actual event device).The analysis results found that the er420 device was returned with no damage in the external components.In addition, two scissored clips were received inside of a plastic bag.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 7 clips as intended.As the device was found to be fully functional, it could not be determined what may have caused the reported incident.The event/reported complaint described could not be confirmed as the device performed without any difficulties noted.A manufacturing record evaluation was performed for the finished device batch number and no non-conformances were identified.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9113006
• MDR Text Key: 199112482
• Report Number: 3005075853-2019-22315
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012597
• UDI-Public: 10705036012597
• 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,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ER420
• Device Lot Number: T93G50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Date Manufacturer Received: 11/11/2019
• Patient Sequence Number: 1