MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT BLADELESS 12X150 STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number	2B12XT
Medical Device Problem Codes	Gas/Air Leak (2946); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 6/26/2023.B3: unknown, assumed first day of month that complaint was reported.D4: batch # v94d2r.Additional information was requested and the following was obtained: "1.Was there an issue with any of the device seals? yes.2.Was insufflation unable to be maintained? yes.3.Was there an issue with the stopcock valve? unknown.".Investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the 2b12xt device was returned with no damage in the external components.In addition, the packaging opened was returned along with the instrument.A leak test was performed and the device was noted to leak with the test probe inserted through the device.As each device is visually inspected and functionally tested during the manufacturing process, it could not be determined what may have caused the reported incident.No conclusion could be reached as to what might have caused the reported event.The reported complaint was confirmed.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown procedure, the device was not air tight.No patient consequences.

• Brand Name: OPT BLADELESS 12X150 STABILITY
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 17199221
• Report Number: 3005075853-2023-04424
• Device Sequence Number: 6798545
• Product Code: GCJ
• UDI-Device Identifier: 10705036014270
• UDI-Public: 10705036014270
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K122512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 2B12XT
• Device Catalogue Number: 2B12XT
• Device Lot Number: 234A15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2023
• Initial Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown