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

Model Number ER320

Device Problems Failure to Form Staple (2579); Failure to Fire (2610)

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

Event Date 12/06/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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: "were there any patient consequences? if yes, please describe.Was there any bleeding? if yes, how was the bleeding controlled? what amount of blood loss (mls) occurred? was a transfusion required? was there any change to the procedure as a result of the event?" 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.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 a general surgery, the clip did not close after applying on tissue.

Manufacturer Narrative

(b)(4).Date sent: 2/23/2023.D4: batch # unk.Additional information was requested and the following was obtained: "were there any patient consequences? if yes, please describe.None reported by the surgeon at the time or after the procedure.Was there any bleeding? if yes, how was the bleeding controlled? no, the device was used on bowel, there was no abnormal bleeding reported, however the bowel was not transected as intended because the device jammed.Another device was used to complete the procedure.What amount of blood loss (mls) occurred? not applicable was a transfusion required? not in the intra-operative period, and none reported by the surgeon during the post-operative period.Was there any change to the procedure as a result of the event? not significant, another device was used to complete the transection." 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 what is meant by "device jammed": -would the device not fire or would the device not feed the clip? -or did the device fire, but the clips were malformed? if so, please describe the shape.".

Manufacturer Narrative

(b)(4).Date sent: 5/9/2023.D4: batch # unk.Additional information was requested and the following was obtained: "the device did not fire from onset".

Manufacturer Narrative

(b)(4).Date sent: 4/11/2023.D4: batch # unk.Additional information was requested and the following was obtained: "device did not fire; second device used.".

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16042364
• MDR Text Key: 308389998
• Report Number: 3005075853-2022-08938
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• 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: 943A61
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male