MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL G2 ART STRA SEALER 35CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number NSLG2S35A

Device Problem Failure to Shut Off (2939)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.

Event Description

It was reported that during an unknown procedure, the device does not cut off during surgery.It was not reported how the procedure was completed.No patient consequence reported.

• Brand Name: ENSEAL G2 ART STRA SEALER 35CM
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8486984
• MDR Text Key: 141197356
• Report Number: 3005075853-2019-17824
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036014515
• UDI-Public: 10705036014515
• Combination Product (y/n): N
• PMA/PMN Number: K122797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2019

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 Expiration Date: 05/31/2023
• Device Catalogue Number: NSLG2S35A
• Device Lot Number: R93J2C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1