MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CIRCULAR MECH XL SEAL 29MM; STAPLE, IMPLANTABLE

Catalog Number	ECS29B
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	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post op to a low anterior resection the surgeon had to bring a patient back to address the bleeding.
Additional Manufacturer Narrative
(b)(4).Date sent 12/5/2024.D4 batch # unk.B3: only event year known: 2024.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: what is the product code? 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? what is the nurses experience with the device? where in the green gap setting scale was the indicator located prior to firing (low-b, middle-b, or high-b)? did the healthcare professional wait 15 seconds after closing the device and then retighten prior to firing? were there any issues with device use/firing? what confirmation was received that the device completed the firing sequence? was the green checkmark visible at the end of the firing? how many counter-clockwise revolutions of the adjusting knob were used to open the device? was there any difficulty removing the device? was a complete transection of the white breakaway washer visually confirmed? were the donuts inspected? if so, please describe.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? 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.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/9/2025.Corrected data: d1, d4.Additional information was requested, and the following was obtained: what is the product code? ecs29b.What were the indications for surgery? colon cancer.Did the patient receive any preoperative chemotherapy or radiation? unknown.Were there any issues experienced with the device in the initial surgical procedure? no issues intra operative.What is the nurses experience with the device? surgeon/pa have extensive experience w device.Where in the green gap setting scale was the indicator located prior to firing (low-b, middle-b, or high-b)? unknown.When i asked pa he says they fired it the same way the last 20 years.Did the healthcare professional wait 15 seconds after closing the device and then retighten prior to firing? yes.Were there any issues with device use/firing? no.What confirmation was received that the device completed the firing sequence? good donuts, no bleeding or bubbles on test.Was the green checkmark visible at the end of the firing? how many counter-clockwise revolutions of the adjusting.Knob were used to open the device? 2.Was there any difficulty removing the device? no.Was a complete transection of the white breakaway washer visually confirmed? yes.Were the donuts inspected? if so, please describe.Yes good donuts.Were there any issues noted with staple formation? if so, please describe the shape and location.What was the total estimated blood loss (ml)? not sure.The patient received (1) unit of blood.Was a transfusion required? yes 1 unit.How was the bleeding addressed? medically.¿ unknown.Addressed in icu.What was the pre and postoperative anti-coagulant and pain management protocol? unknown.Was the bleeding intraluminal or extraluminal? intraluminal.What is the current patient status? discharged.Dr said he treated medically in icu.Transf 1 unit of blood.Patient went home.

• Brand Name: CIRCULAR MECH XL SEAL 29MM
• 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: 20852354
• Report Number: 3005075853-2024-09157
• Device Sequence Number: 15478800
• Product Code: GDW
• UDI-Device Identifier: 10705036022930
• UDI-Public: 10705036022930
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K983536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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: ECS29B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 01/09/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown