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

Catalog Number	2B5LT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 11/20/2025.D4: batch # unk.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.Attempts are being made to obtain the following information.To date, a response has not been received.Should additional information be received, a supplemental report will be submitted.What is surgeon's experience with the xcel bladeless trocars? did the surgeon insufflate the abdomen prior to xcel bladeless trocar insertion? was this trocar the primary port or a secondary port? if a secondary port, was the trocar placed under visualization from a different port? was the trocar inserted using an endoscope? if so what degree of endoscope? what position was the patient positioned in order to minimize the potential of intra-abdominal injury by displacing organs out of the area of penetration? was the trocar tip directed in an area away from major vessels or structures? was excessive force required to insert the trocar? when was the bowel perforation identified? how was the bowel perforation addressed? an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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 an unknown procedure, the consultant inadvertently perforated part of bowel which was required to be repaired.Procedure delayed by 10 minutes.Procedure completed successfully.

• Brand Name: OPT BLADELESS 5X100 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: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 23606406
• Report Number: 3005075853-2025-08927
• Device Sequence Number: 21147032
• Product Code: GCJ
• UDI-Device Identifier: 10705036013709
• UDI-Public: (01)10705036013709(17)UNK(10)UNK
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K032676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 2B5LT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown