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

Catalog Number	NSEAL545RH
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.Attempts are being made to obtain the following information: what does ¿part of the jaw broke off inside the patient¿ mean? did the moveable top jaw break off? did the ceramic (on the lower non-moveable jaw) separate or break off? did the electrode (on the lower non-moveable jaw) separate or break off? please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.To date no response has been provided.If the device or further details are received at a later date, a supplemental medwatch will be sent.
Event or Problem Description
It was reported that during a laparoscopic colon procedure, part of the jaw broke off inside the patient.The piece of the jaw was found.It is unknown how it was found.The procedure was completed with an alternate like device with no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Investigation summary: the device was returned with the upper jaw detached and not returned.In addition, the i-blade was broken and slightly lifted and the cable was cut off.Due to the condition of the device no functional test could be performed.A probable cause of the damage to the jaw could be not allowing thick and fibrous tissues to denature prior to i-blade advancement.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
• MDR Report Key: 8828958
• Report Number: 3005075853-2019-20762
• Device Sequence Number: 3039039
• Product Code: GEI
• UDI-Device Identifier: 10705036000051
• UDI-Public: 10705036000051
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K072493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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: 01/31/2021
• Device Catalogue Number: NSEAL545RH
• Device Lot Number: T92J6F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 08/02/2019
• Patient Sequence Number: 1