MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP* APPLIER W/MECH STOP; APPLIER, SURGICAL, CLIP

Catalog Number LX105

Device Problems Appropriate Term/Code Not Available (3191); Firing Problem (4011)

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

Event Date 10/07/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: unk.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? this is an analysis of a video submitted to ethicon for review: after analysis of the provided video.The ligaclip* applier w/mech stop appears to be non functional; unfortunately, the video does not provide enough evidence to determine the root cause.The practical analysis should provide the necessary evidence to confirm the root cause.Based on the video review, the event describe is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.We value the opportunity to fully analyze the instrument upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.The manufacturing records could not be reviewed as the batch number is unknown.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 coronary artery bypass graft, clips were moving to the proximal side during application on artery or vein.Clips are not getting applied on artery or vein and sometimes cause trauma.

Manufacturer Narrative

(b)(4).Date sent: 11/17/2022.D4: batch # unk.Additional information was requested and the following was obtained: "were there any patient consequences? no was there any bleeding? details are not available if yes, how was the bleeding controlled? details are not available what amount of blood loss (mls) occurred? details are not available was a transfusion required? was there any change to the procedure as a result of the event? details are not available".

• Type of Device: APPLIER, SURGICAL, CLIP
• 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: 15679882
• MDR Text Key: 306785635
• Report Number: 3005075853-2022-07285
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036012849
• UDI-Public: 10705036012849
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

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 Catalogue Number: LX105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/07/2022
• Initial Date FDA Received: 10/27/2022
• Supplement Dates Manufacturer Received: 10/28/2022
• Supplement Dates FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1