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

Catalog Number ER420

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.As a lot/batch was not provided, a device history 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.Please clarify: did not feed properly.Did the clip slowly feed into the jaws of the device? did the clips not feed into the jaws? did multiple clips feed into the jaws of the device? did the clips feed sideways into the jaws of the device?.

Event Description

It was reported that during a laparoscopic colectomy, the clip was not fed into the jaws properly.It was also reported that scissoring occurred during use.The device was used on the blood vessel.Another device was used to complete the case.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Batch # r94a3e.Additional information was requested, and the following was obtained: please clarify: did not feed properly.Did the clip slowly feed into the jaws of the device? no further information is available.Did the clips not feed into the jaws? yes.Did multiple clips feed into the jaws of the device? no further information is available.Did the clips feed sideways into the jaws of the device? no further information is available.Device analysis: the analysis results found that the er420 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 10 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.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8240275
• MDR Text Key: 132931682
• Report Number: 3005075853-2019-15767
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: ER420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/11/2019
• Supplement Dates Manufacturer Received: 01/14/2019
• Supplement Dates FDA Received: 01/28/2019
• Patient Sequence Number: 1