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

Model Number NSLX137C

Device Problems Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Urinary Retention (2119); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch #: x9435k.Attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: how was the delayed thermal spread was identified and observed? what anatomical structure was the device used on when the thermal spread was observed? was there any medical or surgical intervention to address the reduced urine output and/or delayed thermal spread? did the thermal spread alter or change the post-op care of the original procedure in any way? what heat management techniques were used to protect the ureters during the original procedure? are any photos/images available of the thermal spread? why does the surgeon believe the thermal spread was caused by the enseal x1 curve jaw? what is the patient's current status? an analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device lot/batch number, and no non-conformance's were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.

Event Description

It was reported that after a lap hysterectomy the patient experienced delayed thermal spread on both side of the ureters at post op day 7.The thermal spread occurred at the distal third of ureter, near to bladder site.It was found when the patient came in with reduced urine output.

• Brand Name: ENSEAL X1 CURVED 37CM SHAFT
• 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: orla o'mahony ; 475 calle c; guaynabo ; *
• MDR Report Key: 14496482
• MDR Text Key: 292604864
• Report Number: 3005075853-2022-03429
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015468
• UDI-Public: 10705036015468
• Combination Product (y/n): N
• PMA/PMN Number: K172580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NSLX137C
• Device Catalogue Number: NSLX137C
• Device Lot Number: X9435K
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR
• Patient Outcome(s): Required Intervention