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

Model Number	NSEAL535RH
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # t94d85.The product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.The device was received with the top of the i-blade fractured and slightly lifted and the upper jaw detached not returned.In addition, the electrode ceramic was no separation as reported.The device was connected to the generator and it was recognized.Because the i blade was damaged not all functional testing could be performed with the generator.The condition of the blade prevented the functionality of the jaw.The jaw was unable to cycle open and close.It should be noted that product failure is multifactorial.A probable cause of the damage to the i blade could be not allowing thick and fibrous tissues to denature prior to i-blade advancement.As part of ethicon endo surgery 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 information was requested, and the following was obtained: what part of the device is the ¿tip¿? did the electrode ceramic separate or break off? did the i blade get damaged or break off? is the jaw damaged but not broken off? is the top jaw loose but not detached? is the top jaw ptc material damaged? is the black ptc in the upper jaw detached? is the top jaw broken off the of the device? was the missing piece retrieved from the patient? what efforts were made to locate the missing piece? answer = customer didn¿t include any additional information in the official report sent to us.I followed up and wasn¿t able to find the answers to the questions below.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 that during a laparoscopic sigmoid colectomy the tip of the device fell off into the patient.The procedure was completed with a like device with no patient consequences.No additional information.

• 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: 11372644
• Report Number: 3005075853-2021-01071
• Device Sequence Number: 3774418
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/10/2021

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: 08/31/2021
• Device Model Number: NSEAL535RH
• Device Catalogue Number: NSEAL535RH
• Device Lot Number: T94D85
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR