MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CONTOUR CURVED CUTTER STAPLER; STAPLE, IMPLANTABLE

Catalog Number	CS40G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Unspecified Infection (1930)
Date of Event	02/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent 3/28/2025.D4 batch # unk.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.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.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 sequence of events for the 73-year-old patient? what device was used in each procedure? why does the surgeon believe that the device caused or contributed to the peri splenic infected hematoma? what were the indications for surgery? did the patient receive any preoperative chemotherapy or radiation? when was the staple retaining cap removed? what provisions did the surgeon take to ensure the tissue was lying evenly within the jaws? was the device difficult to close? was the device closed and repositioned multiple times prior to firing? was the device difficult to fire? was the distal transection completed in one or multiple firings? what is the scrub's experience with reloading the device? were there any difficulties loading the device? what did they do to ensure that the cartridge was snapped in please prior to closing the device? was the retaining pin placed manually or automatically? what is the current status of the patient? 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.
Event or Problem Description
It was reported that post op to an anterior resection the patient returned to theatre within the same week and underwent a laparotomy.Following the procedure, the patient had to return to theatre due to peri splenic infected hematoma.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/10/2025.Additional information was requested, and the following was obtained: sequence of events for the 73-year-old patient? what device was used in each procedure? why does the surgeon believe that the device caused or contributed to the peri splenic infected hematoma? what were the indications for surgery? did the patient receive any preoperative chemotherapy or radiation? when was the staple retaining cap removed? what provisions did the surgeon take to ensure the tissue was lying evenly within the jaws? was the device difficult to close? was the device closed and repositioned multiple times prior to firing? was the device difficult to fire? was the distal transection completed in one or multiple firings? what is the scrub's experience with reloading the device? were there any difficulties loading the device? what did they do to ensure that the cartridge was snapped in please prior to closing the device? was the retaining pin placed manually or automatically? what is the current status of the patient? 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? response: unfortunately, no further information is available.

• Brand Name: CONTOUR CURVED CUTTER STAPLER
• 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: 21722099
• Report Number: 3005075853-2025-02325
• Device Sequence Number: 9400633
• Product Code: GDW
• UDI-Device Identifier: 10705036012405
• UDI-Public: (01)10705036012405(17)290331(10)C9E01Y
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K040038
• 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): 04/10/2025

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: CS40G
• Device Lot Number: C9E01Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2024
• 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 Sex: Unknown