MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL 5MM ROUND TIP 35CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	NSEAL535RH
Medical Device Problem Codes	Failure to Read Input Signal (1581); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: u93797.Additional information was requested and the following was obtained: the handle was reverted to original position by hand, while the device was cutting the target tissue.There was no effect on the target tissue.The patient is stable.Product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.
Event or Problem Description
It was reported that during a laparoscopic right hemicolectomy, the device was activated and ran the jaws to the end.Then the jaws became not to open.¿replace instrument¿ was displayed.There was an unusual feeling in grasping the handle before the issue occur.The device was used on the blood vessels and mesentery.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• Brand Name: ENSEAL 5MM ROUND TIP 35CM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 12257045
• Report Number: 3005075853-2021-04313
• Device Sequence Number: 14667859
• Product Code: GEI
• UDI-Device Identifier: 10705036000044
• UDI-Public: 10705036000044
• Combination Product (Y/N): N
• PMA/510(K) Number: K072177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/06/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: NSEAL535RH
• Device Catalogue Number: NSEAL535RH
• Device Lot Number: U93797
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 07/31/2021
• Patient Sequence Number: 1