MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL 5MM ROUND TIP 25CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	NSEAL525RH
Medical Device Problem Codes	Difficult to Open or Close (2921); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: u95k1p.Additional information was requested and the following was obtained: did the electrode ceramic separate or break off? no.Did the i blade get damaged or break off? the account is not sure is the jaw damaged but not broken off? no.Is the top jaw loose but not detached? no.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? no.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.
Event or Problem Description
It was reported that during an exploratory laparotomy the tip broke off and the jaws no longer closed.The procedure was completed with a like device with no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/8/2021.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 determined that the nseal525rh device was received the upper jaw damaged at the proximal side.The device was connected to the generator and it was recognized.Because the jaw was damaged not all functional testing could be performed with the generator.The condition of the jaws prevented the functionality of the jaw.The device was unable to cycle open and close.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.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 25CM
• 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: 12615098
• Report Number: 3005075853-2021-06107
• Device Sequence Number: 14349246
• Product Code: GEI
• UDI-Device Identifier: 10705036000037
• UDI-Public: 10705036000037
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

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: 09/30/2022
• Device Model Number: NSEAL525RH
• Device Catalogue Number: NSEAL525RH
• Device Lot Number: U95K1P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2020
• 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; GENERATOR
• Patient Sex: Unknown