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

Model Number NSLX137S

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/19/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 8/23/2022.Batch #: x94z8k.Additional information was requested and the following was obtained: what was the indication for surgery? low anterior resection for cancerous tumor.What was the patient's pre-op anti-coagulation therapy? normal.Were any anti-coagulation drugs given prior to the procedure? no.Did the patient have any anti-coagulopathy disorders? no, it was a vessel sealing isssue.The device did not seal/transect the vessel completely.Had the patient received any radiation or chemo therapy prior to the operation? no.What was the approximate size of the ima? 5mm.Was the ima completely skeletonized when taken? yes, per the surgeon and fellow.Where within the triple burn was the vessel transected? in the middle burn.Was the completion tone heard on all activations? yes.Was the device fully latched for each of the triple burns? yes.Did the patient require any blood transfusions? no.What is the patient's current status? recovering.Is the surgeon interested in speaking with ethicon medical and engineering staff? potentially.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance were identified.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.

Event Description

It was reported that during an lar the surgeon mobilized around the ima.He then triple burned on the ima then transected across to seal off the vessel.It did not seal.There was significant bleeding.He then had to open the patient and complete the case in open status.There was a delay of 2 hours.The patient lost 600 cc's of blood.The patient is currently recovering.

Manufacturer Narrative

(b)(4).Date sent: 9/16/2022.D4 batch #: x94z8k.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the device was received with no apparent damage.The device was tested on the generator and passed all functional testing.The energy output delivered from the device was verified.All tones were heard during functional testing.The device was tested with the test media and no anomalies were found.There were no anomalies noted with the functionality of the device.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reach on the cause of the reported event.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: ENSEAL X1 STRAIGHT 37CM SHAFT
• Type of Device: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): JABIL (TAJUANA)
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 329348013
• MDR Report Key: 15278024
• MDR Text Key: 298426119
• Report Number: 3005075853-2022-05509
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015482
• UDI-Public: 10705036015482
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NSLX137S
• Device Catalogue Number: NSLX137S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR
• Patient Outcome(s): Required Intervention