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

Catalog Number NSLG2C35

Device Problems Entrapment of Device (1212); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.The lot history records were reviewed and the manufacturing criteria were met prior to the release of the lot.Attempts are being made to obtain the following information: when the ¿jaw stuck¿, did the jaws close? when the ¿jaw stuck¿, did the jaws open? did the surgeon attempt to manually open the jaws with his fingers? if no: was the device on a vessel/artery when it would not open? if yes, how was the device removed? (i.E.Cut off, forced opened) if cut off, did this cause a change in the plan of care for the patient? did the removal cause any damage to the vessel/artery? if yes, what is the damage and how was the damage repaired? did the surgeon continue the case with this same device? to date, no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that during a laparoscopic hysterectomy procedure, the jaw stuck.After removing the device from the patient, it was noticed that a clip was in the jaws.It was unknown how the procedure was completed.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).Date sent: 6/22/2018.Batch # r92138.The device was returned with the bottom portion of the i blade out of the lower jaw channel; the lower jaw channel was damaged.The device was connected to the generator and it was recognized.Because of the condition of the device not all functional testing could be performed with the generator.The jaw was unable to cycle open and close.A probable cause of the damage to the jaw could be not allowing thick and fibrous tissues to denature prior to i-blade advancement.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 CURVED 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: 7543087
• MDR Text Key: 109371393
• Report Number: 3005075853-2018-10135
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 20705036014147
• UDI-Public: 20705036014147
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: NSLG2C35
• Device Lot Number: R9272D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2018
• Date Device Manufactured: 01/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1