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

Catalog Number NSLG2S35

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information: what part of the jaw was broken? the complete mobile jaw was the moveable (top jaw) damaged, but still attached to the device? no, the mobile jaw was completely out did the moveable (top jaw) completely break off of the device? yes was the non-movable (bottom jaw) damaged? no, it didn¿t did the ceramic (on the lower non-moveable jaw) separate or break off? no, it didn¿t did the electrode (on the lower non-moveable jaw) separate or break off? no, it didn¿t did this issue cause any tissue trauma? no, it did not generate any type of tissue trauma.

Manufacturer Narrative

(b)(4).Batch # r9325n.Investigation summary: the device was returned with the upper jaw detached and returned and i-blade upper tip broken lifted.In addition, the cable was cut off, however, this is not related with the complaint reported.Due to the returned condition of the device, no 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.

Event Description

It was reported that during an unknown procedure, the doctor was using the device as he normally does.When he was making the resection around the anal sector, he took out the device and observed that a part of the jaw was missing.The doctor and all the pavilion staff began to search for the missing part, until they finally found it.The doctor decided to finish the surgery without another device.There was a delay in surgery of 20 minutes.The surgery was completed successfully without any impact to the patient.

• 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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 9199944
• MDR Text Key: 195189925
• Report Number: 3005075853-2019-22796
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: NSLG2S35
• Device Lot Number: R93L4A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/24/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 11/13/2019
• Supplement Dates FDA Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR