MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT BLADELESS 5X100 STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number 2B5LT

Device Problems Break (1069); Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Date of event is 2020.Event day and event month were not reported.Attempts have been made to retrieve the device.To date, the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.

Event Description

It was reported that during an unknown procedure, the trocar cannula broke off while the doctor was trying to insert the trocar in the incision.The doctor had not gained entry into the abdomen and tried to insert the cannula blindly, and that is when the device broke.It was not reported how the procedure was completed.There were no patient consequences reported.This is all the information known/available regarding this event.

Manufacturer Narrative

(b)(4).Date sent: 3/23/2020.Investigation summary: the analysis results found that the 2b5lt device was received with the sleeve broken in two pieces.In addition, the obturator was not returned for analysis.It is possible that the damage on the sleeve was due to an improper handling of the device.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.

• Brand Name: OPT BLADELESS 5X100 STABILITY
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9776556
• MDR Text Key: 201021962
• Report Number: 3005075853-2020-01362
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036013709
• UDI-Public: 10705036013709
• Combination Product (y/n): N
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

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 Model Number: 2B5LT
• Device Catalogue Number: 2B5LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Manufacturer Received: 02/05/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 03/03/2020
• Supplement Dates FDA Received: 03/23/2020
• Patient Sequence Number: 1