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

Model Number LT400

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Failure to Anastomose (1028); Nausea (1970); Pain (1994); Vomiting (2144); Abdominal Distention (2601)

Event Date 06/01/2023

Event Type  Injury  

Event Description

It was reported that post op to a cholangiography by video laparoscopy, the patient experienced severe abdominal pain, distension, nausea and vomiting.The patient underwent a ct scan of the abdomen and it was discovered that there was a small amount of fluid in the abdominal cavity and notably in the pelvic region, as well as obliteration of adjacent fat, related to previous manipulation.There was a need for surgical re-approach, which was identified that the clip was open.

Manufacturer Narrative

(b)(4).Date sent: 7/11/2023.D4: batch # unk.A manufacturing record evaluation is pending.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: "what is surgeons experience with this device? were the clips visualized endoscopically during the initial surgical procedure? how many total clips were used? which firing did the incident occur on? were there any complications during the initial procedure? what type of clip applier was used? please provide product code or serial number if available.How old is the clip applier that was used? were there any noticeable defects in the clip applier used? how long after initial procedure was the leak discovered? was the reoperation open or laparoscopic? please describe the shape of the clips found during reoperation.Does the surgeon believe that there is an alleged deficiency against the clip applier used? does the surgeon believe that there is an alleged deficiency against the clips used? what is the current patient status? is the device available for return? " 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.

Manufacturer Narrative

(b)(4).Date sent: 8/2/2023.An analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.

• 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: 17302454
• MDR Text Key: 318831702
• Report Number: 3005075853-2023-04849
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012832
• UDI-Public: 10705036012832
• 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,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LT400
• Device Catalogue Number: LT400
• Device Lot Number: 729A28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention