MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT BLADELESS 12X100 STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	2B12LT
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	07/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 8/5/2025.D4 batch # unk.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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.Additional information was requested, and the following was obtained: 1.Any visible broken part? unk.2.What part broke of the device broke? unk.3.Could you please specify how the device was damaged? unk.4.Did any pieces fall into the patient? no, they did not.5.If yes, how were they retrieved? unk.6.Will all pieces be returned with the device? unk.7.If no, were they discarded? unk.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during a robot-assisted gastric malignant tumor resection for gastric cancer, when the forceps were inserted, there was a hissing sound like air leak.When the trocar was replaced, the sound when the forceps was inserted was resolved, but an air leak did not resolve, and when checked the ez access of the umbilicus that was being used at the same time, it was found to be torn, so it was replaced and air leak resolved.It is unknown whether there was a problem with the trocar as a result.The device was used on the abdominal wall.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent 8/18/2025 d4 batch #a97r7a corrected data d4: udi# investigation summary the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the 2b12lt device was returned with no damage in the external components.A leak test was performed and the device was noted to leak inserting and removing the test probe through the device.As each device is visually inspected and functionally tested during the manufacturing process, no conclusion could be reached as to what might have caused the reported event.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this batch.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as to what might have caused the reported event.The reported complaint was confirmed.A manufacturing record evaluation was performed for the finished device batch a97r7a number, and no non-conformances were identified.

• Brand Name: OPT BLADELESS 12X100 STABILITY
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 22715116
• Report Number: 3005075853-2025-06184
• Device Sequence Number: 9583456
• Product Code: GCJ
• UDI-Device Identifier: 10705036014218
• UDI-Public: (01)10705036014218(17)300331(10)A97R7A
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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 Catalogue Number: 2B12LT
• Device Lot Number: A97R7A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown