MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL 45 CM SHAFT, CURVED JAW; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Model Number NSLX145C

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/06/2023

Event Type  Injury  

Event Description

It was reported that post op to a gastric sleeve a ct scan revealed a bleed from the gastric edge discovered while in recovery.It self resolved but the patient received one unit of blood.They have since been discharged and are doing fine.

Manufacturer Narrative

(b)(4).Batch #: unknown.Additional information was requested and the following was obtained: 1.Please clarify/what is meant by the gastric edge? the cut edge on the greater curve of the sleeves stomach.2.What was the approximate amount of time between the operation and the ct scan where the bleed was found? 48 hours.3.Can the nature of the post-op bleed be described, i.E.Oozing, major, etc.? slow persistent ooze that dropped her hemoglobin from 14 down to 7.1 in 72 hours.4.Was the source of the bleeding identified? no, but i suspect the cut edge of the short gastric vessels.5.If yes, was it where the enseal device was used? yes.The enseal was used to ligate the short gastric.6.What was the patient¿s post -op care besides the unit of blood and was it altered in any way due to the bleed? pt was kept npo for 48 hours.Stopped all anticoagulation.Those orders are not standard.7.Did the surgeon experience any device issues or complications during the original surgery? no issues but had to re-seal a couple of vessels along the greater curve because there was breakthrough bleeding.8.Were there any hemostasis difficulties during initial procedure with enseal device? see #7.9.In surgeon¿s opinion, what is the potential cause or what contributed to the post-op bleed? i believe a vessel along the short gastrics reopened.10.What is the patient¿s current status? pt was seen for her two week post op visit and is doing fine.The following information was requested, but unavailable: did the patient have any underlying conditions that could cause or contributed to the post-op complications? 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.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.

• Brand Name: ENSEAL 45 CM SHAFT, CURVED JAW
• Type of Device: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO SURGERY, INC. (CINCINNATI)
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 16644221
• MDR Text Key: 312331466
• Report Number: 3005075853-2023-02105
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015499
• UDI-Public: 10705036015499
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NSLX145C
• Device Catalogue Number: NSLX145C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2023
• 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
• Treatment: GENERATOR
• Patient Outcome(s): Required Intervention