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 Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: u9335u.Attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: in the event description it states: ¿tip broke off" 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? 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 that during a colon procedure the tip of the device broke off and fell into the patient.The tip was found visually and retrieved.The generator did not alarm of give any indication that the tip had broken off.The procedure was completed with a like device with no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/11/2020.Investigation summary the device was returned with the i-blade upper tip broken off, not returned, and the upper jaw detached and 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.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.A probable cause of the damage to the jaw could be not allowing thick and fibrous tissues to denature prior to i-blade advancement.

• 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: 10358106
• Report Number: 3005075853-2020-03954
• Device Sequence Number: 972247
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2020

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
• Device Lot Number: U9335U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 08/11/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR