MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL G2 STRAIGHT JAW 35CM; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Model Number NSLG2S35

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2019

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.A manufacturing record evaluation was performed for the finished device and no non-conformances were identified.Additional information was requested, and the following was obtained: what part of this device was broken? branch that closes (top jaw).Was the moveable (top jaw) damaged, but still attached to the device? no.Did the moveable (top jaw) completely break off of the device? yes.Was the non-movable (bottom jaw) damaged? no.Did the ceramic (on the lower non-moveable jaw) separate or break off? no.Did the electrode (on the lower non-moveable jaw) separate or break off? no.Did this cause a change in the plan of care for the patient? no.

Event Description

During use, device locked with closed branches, and during cleaning phase with wet gauze, there was the detachment of one branche.The generator did not report error or warning.No adverse event reported.

Manufacturer Narrative

(b)(4).Date sent: 1/13/2020.Investigation summary: the device was returned with the upper jaw detached returned and the i-blade upper tip broken lifted.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 G2 STRAIGHT JAW 35CM
• Type of Device: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9468534
• MDR Text Key: 203522652
• Report Number: 3005075853-2019-24298
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036014188
• UDI-Public: 10705036014188
• Combination Product (y/n): N
• PMA/PMN Number: K112033
• 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: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: NSLG2S35
• Device Catalogue Number: NSLG2S35
• Device Lot Number: P94401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Date Manufacturer Received: 12/17/2019
• Patient Sequence Number: 1
• Treatment: GENERATOR.