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

Model Number	LT300
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Dyspnea (1816); Pain (1994); Paresis (1998); Sepsis (2067); Vomiting (2144)
Date of Event	01/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a cholecystectomy procedure by videolaparoscopy, a procedure that occurred without complications.On the following day, patient presented with distension and abdominal pain, gases, vomiting and dyspnea, with progressive worsening in subsequent days, requiring hospitalization in the icu with a diagnostic hypothesis of abdominal sepsis.Patient submitted to laparoscopy diagnoses,4 days after first surgical procedure.Bile extravasation identified in the hepatic pedicle region, verified cystic duct with important escape of bile by detachment of the metal clip used in the previous procedure.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/18/2023.D4: batch # unk.The lot/ batch history records were reviewed and certified by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.The certificate records are accessible through external manufacturing.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.

• Common Device Name: 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 ; *
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 17347583
• Report Number: 3005075853-2023-05062
• Device Sequence Number: 6068406
• Product Code: FZP
• UDI-Device Identifier: 10705036012825
• UDI-Public: 10705036012825
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K830503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LT300
• Device Catalogue Number: LT300
• Device Lot Number: 824A03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown