MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL 5MM ROUND TIP 45 CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	NSEAL545RH
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.Additional information was requested and the following was obtained: what part of the device is the ¿tip¿? jaw of probe.Did the electrode ceramic separate or break off? no.Did the i blade get damaged or break off? no.Is the jaw damaged but not broken off? broken off.Is the top jaw loose but not detached? detached is the top jaw ptc material damaged? no.Is the black ptc in the upper jaw detached? no.Is the top jaw broken off the of the device? yes.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
Event or Problem Description
It was reported that during an unknown procedure the tip was broken.There were no patient consequences.There were no patient consequences.
Additional Manufacturer Narrative
Pc-(b)(4).Date sent: 3/28/2022 batch #: u93096.Investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the nseal545rh device was returned with the upper jaw detached and not returned.In addition, it was received with the top of the i-blade broken off not returned.The device was connected to the generator and it was recognized.Because the jaw was detached not all functional testing could be performed with the generator.A probable cause of the damage to the jaw could be not allowing thick and fibrous tissues to denature prior to i-blade advancement.As described in the ifu: do not use excessive force on the closing handle to close the jaws; grasp only as much tissue as will fit between the jaws where the current will pass.Greater amounts of tissue require more closing handle force.Excessive force could damage the device.Please reference the instruction for use for more information: as part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: ENSEAL 5MM ROUND TIP 45 CM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 12506810
• Report Number: 3005075853-2021-05614
• Device Sequence Number: 3694749
• Product Code: GEI
• UDI-Device Identifier: 10705036000051
• UDI-Public: 10705036000051
• Combination Product (Y/N): N
• PMA/510(K) Number: K072493
• 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): 08/25/2021

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: NSEAL545RH
• Device Catalogue Number: NSEAL545RH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2020
• 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
• Patient Sex: Unknown