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

Model Number ER420

Device Problems Loose or Intermittent Connection (1371); Failure to Form Staple (2579); Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/24/2019

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 additional information and the device: by loose, does it mean clips not closed all the way? or did clips fall off of vessel after applied? to date no response has been provided and no device has been received.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that during an unknown procedure, clip did not deploy.Clips were loose.There was a delay to procedure of fifteen minutes but all clips were extracted and there was no adverse event for the patient (no patient consequence).A new device was opened and the case was successfully completed.

Manufacturer Narrative

(b)(4).Date sent: 3/3/2020.D4: batch # t93d6l.Investigation summary 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 5 clips as intended.The event 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: 9656335
• MDR Text Key: 199106958
• Report Number: 3005075853-2020-00691
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ER420
• Device Catalogue Number: ER420
• Device Lot Number: T93G50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Date Manufacturer Received: 02/10/2020
• Patient Sequence Number: 1
• Patient Age: 32 YR