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

Catalog Number NSLG2C35A

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Code Available (3191)

Event Date 09/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information asked for but unknown or not provided during initial contact.Should the information be provided later, a supplemental medwatch will be sent.Batch #m91247.The device was received with the i-blade lower tip broken off not returned.The device was connected to the generator and it was recognized.Because the i blade was damaged not all functional testing could be performed with the generator.The condition of the blade prevented the functionality of the jaw.The jaw was unable to cycle open and close.A probable cause of the damage to the i blade could be not allowing thick and fibrous tissues to denature prior to i-blade advancement.The batch history records were reviewed with no anomalies noted during the manufacturing process.

Event Description

It was reported that during a lap total hysterectomy, the i-blade was broken off when it was cutting the vaginal stump.The doctor did not notice that the i-blade broke off at the time.After a while, the doctor felt uncomfortable in opening/closing the jaws, so the first device was replaced with the 2nd one.When the sales rep who attended the operation checked the 1st device, it was found that the i-blade of the lower jaw was broken off.The sales rep told the doctor that the i-blade was missing.Then, the doctor tried to find the broken piece after the uterus was removed, but the broken piece could not be found inside the abdominal cavity or the suction bag.Therefore, the abdominal was closed.After that, the patient was x-rayed after closing the incision.Two shadows were found inside the patient, but it was not able to identify whether the shadows were the broken piece of the i-blade.After the operation, the patient was informed of a possibility that a fragment of the instrument was remaining inside the abdominal cavity.As for now, the patient is being hospitalized.

• Brand Name: ENSEAL G2 ARTICULATING
• 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: 5211135
• MDR Text Key: 31054614
• Report Number: 3005075853-2015-07158
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122797
• 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
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2020
• Device Catalogue Number: NSLG2C35A
• Device Lot Number: M91H6D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2015
• 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