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

Model Number	NSEAL545RH
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: p9aa2n.Additional information was requested and the following was obtained: did the electrode ceramic separate or break off? the ceramic broke off.Did the i blade get damaged or break off? the blade was bent back.Is the jaw damaged but not broken off? the bottom jaw was intact.Is the top jaw loose but not detached? the top jaw was bent and the ceramic covering was broken.Is the top jaw ptc material damaged? yes.Is the black ptc in the upper jaw detached? yes.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.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported during a bariatric procedure the jaw broke.There were no patient consequences reported and there is no additional information.
Additional Manufacturer Narrative
(b)(4).Date sent: (b)(6) 2021.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, the top of the i-blade was fractured and lifted.Upon visual inspection, it was noted that the electrode and ceramic were returned with no apparent damage.Due to the condition of the device returned we were unable to investigated further the ptc detached as reported.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 and iblade 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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• 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
• MDR Report Key: 11753333
• Report Number: 3005075853-2021-02417
• Device Sequence Number: 19875836
• Product Code: GEI
• UDI-Device Identifier: 10705036000051
• UDI-Public: 10705036000051
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2021

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: 11/30/2022
• Device Model Number: NSEAL545RH
• Device Catalogue Number: NSEAL545RH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 05/26/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR