MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL X1 STRAIGHT 37CM SHAFT; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Model Number	NSLX137S
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191); Firing Problem (4011)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a sigmoid colectomy the surgeon had a post op bleed in their department after using the device.The patient returned to the theatre due to the post op bleed.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/18/2023.B3: unknown; captured as awareness date.D4 batch #: unknown.Additional information was requested and the following was obtained: the surgeon did not experience any major problems during the case.Only that the knife blade did not seem to cut and instead pushed the tissue to the end.He thought this may have something to do with the overall result of the patient being brought back to theatre with a bleed.What was the original procedure? sigmoid colectomy.What is the surgeon's experience with this device? felt the knife blade isn¿t sharp enough or the jaws are not gripping the tissue well enough.What was the exact product code was used in the original procedure? nslx137s.Did the patient have any pre-existing conditions that would make hemostasis challenging? crones.Were there any issues with the device during the initial procedure? just not cutting effectively.What were the signs and symptoms of the post-op bleed? bleeding and rushed back in for further operation.How was the post-op bleeding managed? another operation then haemostats.Was a re-operation required? if so, open or laparoscopic? laparoscopic.Was the source of the bleeding identified? if yes, what was it? not sure exactly.What was the total amount of blood loss (ml)? not sure.What is the patient's current status? home and well.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.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/20/2023.Additional information was obtained: an internal rapid response call was held on (b)(6) 2023 to discuss the hemostasis issues the customer experienced.The rep indicated that the customer has been using enseal for about 9 months and had the whole department switch over towards the end of last year.The device was well liked.The rep received a call about 1 month ago where she was informed, they had a post-op bleed that had to be taken back to the theatre.The post-op bleed occurred after the clinical lead used the device.The post-op bleed occurred right away after completing a right hemi.They had to call the patient straight back into the theatre.The patient was a crohns patient.During the original procedure they felt the enseal straight jaw wasn¿t sealing as well as it should have been.It also seemed the knife wasn¿t sharp enough and it was pushing the tissue some when attempting to cut the tissue.

• Brand Name: ENSEAL X1 STRAIGHT 37CM SHAFT
• Common Device Name: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): JABIL (TAJUANA)
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16952522
• Report Number: 3005075853-2023-03368
• Device Sequence Number: 3301283
• Product Code: GEI
• UDI-Device Identifier: 10705036015482
• UDI-Public: 10705036015482
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K112033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2023

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: NSLX137S
• Device Catalogue Number: NSLX137S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 06/20/2023
• 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: Unknown