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

Catalog Number NSLG2XXX

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/12/2022

Event Type  Injury  

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra) for patients undergoing unknown procedure.The reported complication as per icd 9 & 10 categorization experienced by the following with corresponding intervention: 507 patients g2 articulating (general surgery: 430, gynecologic surgery: 30, thoracic surgery: 18, urologic surgery: 29) 1,669 patients x1 large jaw (general surgery: 1,347, gynecologic surgery: 201, thoracic surgery 32, urologic surgery: 89) and had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, bleeding.1 patients g2 articulating (general surgery: 1, gynecologic surgery: 0, thoracic surgery: 0, urologic surgery: 0) 0 patients x1 large jaw (general surgery: 0, gynecologic surgery: 0, thoracic surgery 0, urologic surgery: 0) had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, thermal injury.405 patients g2 articulating (general surgery: 331, gynecologic surgery: 39, thoracic surgery: 23, urologic surgery: 12) 1,231 patients x1 large jaw (general surgery: 996, gynecologic surgery: 138, thoracic surgery 32, urologic surgery: 65) had peri-operative complication after the procedure with the use of the device and before the discharge of the index hospitalization were defined with the diagnosis code, blood transfusion.This is for ethicon.

Manufacturer Narrative

(b)(4).Date of event: unknown; captured as awareness date.Batch #: unknown.This report is related to a clinical evaluation report from a related research activity database; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided.

• Brand Name: ENSEAL G2 CURVED JAW
• Type of Device: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; *
• MDR Report Key: 14335938
• MDR Text Key: 291198281
• Report Number: 3005075853-2022-02946
• Device Sequence Number: 1
• Product Code: GEI
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NSLG2XXX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/12/2022
• Initial Date FDA Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR
• Patient Outcome(s): Required Intervention