MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL G2 SUPER JAW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	NSEALX22L
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2019
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.
Event or Problem Description
It was reported that during a low anterior resection, during mesorectal dissection, the internal mechanism of the movable top jaw broke.The movable top jaw was damaged/loose and was still attached to the device, but was not able to open or close.The surgeon attempted to manually open the jaws and the device was not on a vessel or artery when it would not open.The surgeon did not continue the case with the same device.There was no adverse consequence for the patient.
Additional Manufacturer Narrative
(b)(4).Investigation summary: the device was received with no apparent damage.During mechanical testing the jaws would not open nor close completely so no functional testing could be performed.The device was disassembled and the proximal gear was missing two teeth and they were not returned.The damage to the proximal gear prevented the jaws from opening and closing.Although the gear teeth may have been discarded or lost after the device was removed from the surgical field, our findings raise the possibility that the pieces could have been left in the patient, though this device is used in open procedures and the gear and gear teeth are in the handle of the device.We are sending this letter in an effort of helpful transparency in the event of an unexpected post-operative complication.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Batch # p94k33.Additional information received: sales rep informed us that the lot of the device being returned is p94k33.However, please note the original packaging and the internal tyvek packaging stated the lot was r92077 (which was originally reported).Lot number is r92077.Batch number is p94k33.Corrected data: device manufacture date is 12/19/2017.

• Brand Name: ENSEAL G2 SUPER JAW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8338149
• Report Number: 3005075853-2019-16602
• Device Sequence Number: 2253379
• Product Code: GEI
• UDI-Device Identifier: 10705036013808
• UDI-Public: 10705036013808
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2019

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: 12/31/2019
• Device Catalogue Number: NSEALX22L
• Device Lot Number: R92077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 02/22/2019; 02/04/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 02/28/2019; 03/22/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR