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

Catalog Number NSLG2S35

Device Problems Component Falling (1105); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 10/21/2016.(b)(4).Additional information was requested and the following was obtained: was it the top jaw missing from the device? was there any patient consequence due to the extended 60 minutes for the retrieval of the jaw? yes it was the top jaw.I will send on the photo.There were no reported patient consequences with the extended operation time.The device was received with the upper jaw detached returned.In addition, the cable was cut off.The cable cut off is not related with complaint.Due to the returned condition of the device, no functional testing could be performed with the generator.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, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported that during a total laparoscopic hysterectomy procedure, the doctor had just started to use the device on the broad ligament and within minutes of use the bottom jaw of the device fell off into the patient.The device had not been used prior to being used on the broad ligament.It took around an hour to retrieve the jaw as it was very difficult to find as it had fallen onto bowel.In fact, to find the jaw, the table had to be tipped so that the bowel would move around.It is unknown how the procedure was completed.One device will be returned.

Manufacturer Narrative

(b)(4).This analysis is based on a video sent by the account and is not of an instrument.The physical analysis of the instrument can be reviewed under analysis: (b)(4).Image 1: the image provided by the account appears to be that of an nslg2c35 instrument.In the image the upper jaw of the instrument is detached.No conclusion could be made as to what caused the jaw damage.The picture reviewed adds no additional information to the actual analysis performs.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• 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: 6046710
• MDR Text Key: 58308741
• Report Number: 3005075853-2016-05994
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/06/2016

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: 05/22/2021
• Device Catalogue Number: NSLG2S35
• Device Lot Number: N91Z2A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2016
• Initial Date FDA Received: 10/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2016
• 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
• Treatment: GENERATOR