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

Model Number	NSLX145C
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post op to the unknown procedure, the surgeon had a patient bring back from a case on (b)(6) 2022 the following day due to bleeding.The surgeon said he was not sure the cause of the bleeding the patient experienced.The surgeon irrigated the abdomen and applied vistaseal as well as another hemostasis product.Last update, patient was doing okay.
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.Additional information was requested and the following was obtained: he had 1 case that he had to bring back for a re-bleed.It was a friday procedure with the bring back being on saturday.The surgeon couldn¿t tell where the bleed was coming from, and it had stopped bleeding by the time he was in the re-operation.Did the enseal sticking issues/tissue tearing occur in the procedure? there was no concern about sticking issues.Any bleeding source identified in the re-operation? not to my knowledge.If so, can the surgeon determine if it was where the enseal device was used? unknown.Were there any further patient consequence? not that we are aware of.The surgeon reports that he was not able to locate the source of the bleed on the case that required re-operation.He suspects that it could have been related to the enseal or the echelon, but could not determine the source.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.A generator log review was performed.Without a device i.D.A general review of the gen11 logs was summarized.It was noted that the percent end tone would appear to be low in some of the cases.Unless the surgeon was doing a significant portion of the firings on avascular tissue we would recommend to wait for the cycle complete tone.Waiting for the end tone ensures full seal reliability.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
• Common Device Name: 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: orla o'mahony ; 475 calle c; guaynabo ; *
• MDR Report Key: 14360917
• Report Number: 3005075853-2022-03065
• Device Sequence Number: 17179429
• Product Code: GEI
• UDI-Device Identifier: 10705036015499
• UDI-Public: 10705036015499
• Combination Product (Y/N): N
• PMA/510(K) Number: K172580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2022

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: NSLX145C
• Device Catalogue Number: NSLX145C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male