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

Model Number 2B5LT

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a laparoscopic cholecystectomy, the device "broke about one inch down." the trocar sleeve was broken almost in two pieces, if not for the inner trocar.No pieces were lost from the trocar.A second trocar was used to complete the case.There were no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 7/20/2020.Investigation summary: the analysis results found that the 2b5lt device was returned with the obturator cannula and sleeve damaged.Due to the condition of the device, no functional testing could be performed to evaluate the reported incident.It is possible that the damage 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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• 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: 10182482
• MDR Text Key: 196466097
• Report Number: 3005075853-2020-03155
• 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: 05/29/2020

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: 06/19/2020
• Initial Date Manufacturer Received: 05/29/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 06/26/2020
• Supplement Dates FDA Received: 07/20/2020
• Patient Sequence Number: 1