MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. POWERED PLUS LONG 45; STAPLE, IMPLANTABLE

Catalog Number	PLEE45A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent 1/15/2026.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.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.No lot or batch number was provided therefore a device history could not be done.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: was there any evidence of staple malformation noted throughout the care of the patient? did the surgeon wait 15 seconds prior to firing? what tissue was being fired upon with the blue reload? 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 post op to a bypass procedure there was a patient who had bleeding into the stomach.I asked him to tell me more about his perceptions about the cause of bleeding and he started by saying that he has been doing bariatric surgery for more than 20 years and started using our ats, but he believes that the problem was because johnson did not evolve to the tri-staple system where he believed this was the reason because he does not have this statistic with materials with this characteristic.First, i asked him for patient data and a report on what happened so that we could locate the materials, although it is not possible to analyze the materials involved due to disposal, we will make a report to the competent bodies and we could track problems reported in other locations of the same lot.I went on to inform that in the surgery in which his assistant that was taking place concomitantly in another room, i signaled that the doctor was not respecting the proximal limit of the tissue in the stapler's jaw, where tissue was beyond marking, where he would be at risk of cutting without a staple, dr.Confirmed during this conversation that the team's concern is regarding the amount of package loads, as there are only 6 loads, they try to save on stapling.I informed dr.That the hospital did not refuse in any procedure that required the sending of more loads and that even or two other procedures that would come in sequence already had 2 extra loads per patient.Dr.Said that this could be the reason for the bleeding and when i asked for the patients' information, he said that he did not want to touch this hornet's nest and that they would follow up on future cases.As an action plan, we are aligning a new training agenda with his team in the ceteb room and suggested the need to involve dr.In a conversation with the surgeon's team.

• Brand Name: POWERED PLUS LONG 45
• Common Device Name: STAPLE, IMPLANTABLE
• 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: 24079286
• Report Number: 3005075853-2026-00512
• Device Sequence Number: 5878965
• Product Code: GDW
• UDI-Device Identifier: 10705036015345
• UDI-Public: 10705036015345
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K163454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/15/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PLEE45A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: B12LT.; CB12LT.; GST45B.; GST45W.; HARH45.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown