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

Model Number ER320

Device Problems Mechanical Problem (1384); Failure to Form Staple (2579)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2020

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 additional information and to retrieve the device.To date, no additional information has been received and no device has been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent: please clarify " the jaw overlaps", was the jaw misaligned ? if other, please specify.Please provide the status of the device(s) as it has not been received for analysis.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during an unknown procedure, the clips "get out like x shape from the jaw overlaps.Surgeon used oversewing technique instead of clip applier.There was no patient consequence.

Manufacturer Narrative

(b)(4) date sent: 1/4/2021 h2: additional information received: please clarify " the jaw overlaps," was the jaw misaligned ? if other, please specify.No.I mean the clips take x shape when it get out from the jaw.H6: medical device problem code: is only failure to form staple (a050704).The device did not have a damaged jaw so mechanical problem (a05) medical device problem code should be removed.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 11033722
• MDR Text Key: 222699331
• Report Number: 3005075853-2020-06974
• 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: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ER320
• Device Catalogue Number: ER320
• Device Lot Number: U4063Y
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2020
• Patient Sequence Number: 1