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

Catalog Number NSEALX22L

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Additional information received: about the patient: did the patient have permanent or serious damage? no, the patient did not have any serious injury, when the product failed it was replaced for a new one.Did the patient need hospitalization or had hospitalization prolonged due to a product problem? no, it was not necessary to extend hospitalization period.

Event Description

It was reported that during a hysterectomy, the jaw of the super jaw clamp did not open after being activated and the cycle finished, the equipment presented an error code that said to change the device due to malfunction.There were no patient consequences.

Manufacturer Narrative

(b)(4).Batch # p92301.Investigation summary 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).In addition no issues were noted with opening and closing of the jaws.No alert screens were displayed during testing.There were no anomalies noted with the functionality of the device.The ¿replace instrument¿ alert screen is displayed after receiving two consecutive alert screens and is advising of a potential issue with the instrument.However; no alert screens were displayed during testing.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 SUPER JAW
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7457837
• MDR Text Key: 106704650
• Report Number: 3005075853-2018-09313
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 20705036013805
• UDI-Public: 20705036013805
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/29/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: NSEALX22L
• Device Lot Number: P93M9M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Initial Date Manufacturer Received: 03/29/2018
• Initial Date FDA Received: 04/25/2018
• Supplement Dates Manufacturer Received: 03/29/2018
• Supplement Dates FDA Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR