MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL G2 STRAIGHT JAW 45CM; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Catalog Number	NSLG2S45
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Event or Problem Description
It was reported that during a gyn exploratory laparoscopy procedure the enseal device when closed would not release very well (jam and hard to open).A second device with same lot number was opened and same issue however this time a black thin piece of metal (or wire) came out of the jaws.No patient complications reported.Used a kleppinger to seal tissue.
Additional Manufacturer Narrative
(b)(4).Batch # r93j00.The device was received with no apparent damage.The device was tested on the generator and passed all functional testing.The energy output delivered from the device was verified.All three tones were heard during functional testing (tone 1 is heard when the energy activation button is pressed; tone 2 is heard when tissue impedance threshold is reached and tone 3 is heard when the cycle is complete).No issues were noted with opening and closing of the jaws.There were no anomalies noted with the functionality of the device.The batch history record was reviewed, and no defects, nc¿s or protocols related to the complaint, were found during the manufacturing process.

• Brand Name: ENSEAL G2 STRAIGHT JAW 45CM
• Common Device Name: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8016972
• Report Number: 3005075853-2018-14043
• Device Sequence Number: 1368837
• Product Code: GEI
• UDI-Device Identifier: 10705036014195
• UDI-Public: 10705036014195
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K112033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

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: 05/31/2023
• Device Catalogue Number: NSLG2S45
• Device Lot Number: R93P1K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR