MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*EXTRA TITANIUM CLIPS; CLIP, IMPLANTABLE

Model Number LT300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure to Anastomose (1028)

Event Date 06/01/2022

Event Type  Injury  

Event Description

It was reported that in the immediate postoperative period of a cholecystectomy, fluid was observed in the cavity and the day after the procedure the patient was taken back to the surgical center and it was not possible to locate where the bile leak was.A drain was placed and the patient was kept in the icu.After a while, the patient started with hemodynamic instability because he had cardiovascular problems and died in a few days.

Manufacturer Narrative

(b)(4).Batch # unk.(b)(4).Additional information was requested and the following was obtained: were the clips viewed endoscopically during the initial surgical procedure? yes.Were there any intraoperative complications with the initial procedure? no.Were there any intraoperative complications with the reoperation? at the prior to loading, can you please confirm each of clip cartridges were placed in the lc800 base metal? i don't have information.Please confirm the brand and product code of the clip applier used with the lt300 clips? i have no information because i was not in surgery.I knew the report after were malformed or scissored clips observed? if yes, please describe shape.Not that the doctor has comment.Prior to use, did the or staff confirm alignment of the jaws of the clip appliers as requested in the ifu? i don't have information because i was not in the room two other events were also reported, (b)(4) and (b)(4), were these all 3 separate patients and events? yea.These are other events and there are even more according to doctors.Obito has only known about this but has cases of proloned hospitalization and more exams and procedures taking wear to the patient and doctor as well as discomfort to the hospital leadership.Is the surgeon experienced with the use of j&j clip appliers?yes.Did the surgeon experience any difficulties using the clip applier? if so, please describe.At the.What is the surgeon suggesting caused the cardiovascular problems that lead to the hemodynamic instability? patient already had cardiovascular problem.Doctor reports that the dps problems of the surgery with the leakage of the cystic duct leaded to instalibility but was not the cause of death.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: it was stated that, "two other events were also reported, (b)(4) and (b)(4), were these all 3 separate patients and events? yea.These are other events and there are even more according to doctors.Obito has only known about this but has cases of proloned hospitalization and more exams and procedures taking wear to the patient and doctor as well as discomfort to the hospital leadership." please confirm the specific number of patient events.Have any of these events been previously reported to ethicon? if yes, please provide complaint file number.For each patient event please provide: event date, product code and lot number involved, procedure, and event description.Was there any adverse patient outcome? if yes, was there any medical or surgical intervention performed? investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 15679360
• MDR Text Key: 302475637
• Report Number: 3005075853-2022-07278
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012825
• UDI-Public: 10705036012825
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K830503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LT300
• Device Catalogue Number: LT300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention