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

Catalog Number NSLG2S45

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) date sent: 6/9/2016.Batch # unk the lot history records were reviewed and the manufacturing criteria were met prior to the release of the lot.

Event Description

It was reported that during a laparoscopic sigmoid colon resection the jaw of one device snapped off and fell into the patient.The jaw was removed.Another device was employed to proceed with the case, but the jaw on it broke.No pieces were reported to have fallen off or into the patient.It is unknown how it broke or where precisely.The procedure was still being conducted when the complaints were reported.A third device was being used to complete the procedure.Neither of the devices were used on bone.It is unknown if the smaller piece that broke off into the patient is being returned with that device.There were no patient consequences reported.

• Brand Name: ENSEAL G2 STRAIGHT JAW
• Type of Device: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5710658
• MDR Text Key: 48116966
• Report Number: 3005075853-2016-03240
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: NSLG2S45
• Device Lot Number: N9181F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1