MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*LINEAR STAP RELOAD; STAPLE, IMPLANTABLE

Catalog Number	XR60B
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	03/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent 3/28/2025.Mw # (b)(4).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 the bleeding coming from the common channel closure or the side-to-side anastomosis? what were the indications for surgery? did the patient receive any preoperative chemotherapy or radiation? were there any issues experienced with the device in the initial surgical procedure? were there any issues noted with staple formation? if so, please describe the shape and location.What was the total estimated blood loss (ml)? was a transfusion required? how was the bleeding addressed? what was the pre and postoperative anti-coagulant and pain management protocol? was the bleeding intraluminal or extraluminal? what is the current patient status? what surgical procedure was performed? what anatomical structures was the device fired on? were other stapling or suturing devices used when creating the anastomosis? what device was used to create the common channel? what was used to close the common opening? were there any issues experienced with the device in the initial surgical procedure? was the device difficult to fire? how were the post-operative issues identified? did the device cut at all? 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 an unknown procedure the patient had significant bleeding after using a tlc75 and a tx60 stapler on them.The surgeon certainly knows how to use the devices.Bled 3 days post op.Patient had to be brought back to the or.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/14/2025.Was the bleeding coming from the common channel closure or the side-to-side anastomosis? what were the indications for surgery? did the patient receive any preoperative chemotherapy or radiation? were there any issues experienced with the device in the initial surgical procedure? were there any issues noted with staple formation? if so, please describe the shape and location.What was the total estimated blood loss (ml)? was a transfusion required? how was the bleeding addressed? what was the pre and postoperative anti-coagulant and pain management protocol? was the bleeding intraluminal or extraluminal? what is the current patient status? what surgical procedure was performed? what anatomical structures was the device fired on? were other stapling or suturing devices used when creating the anastomosis? what device was used to create the common channel? what was used to close the common opening? were there any issues experienced with the device in the initial surgical procedure? was the device difficult to fire? how were the post-operative issues identified? did the device cut at all? the surgeon has been unwilling to share the answers to the questions.I spoke directly with the or nurse director to ask him to intervene.He placed the questions in the surgeon's hands with no luck getting answers.

• Common Device Name: STAPLE, IMPLANTABLE
• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 21722376
• Report Number: 3005075853-2025-02330
• Device Sequence Number: 14384703
• Product Code: GDW
• UDI-Device Identifier: 10705036013464
• UDI-Public: 10705036013464
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: XR60B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 05/14/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White