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

Catalog Number	CS40B
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure when the surgeon fired the single-use stapler during patient¿s open bowel surgery, the stapler would not release from the tissue.The surgeon was required to extend the incision into the mesentery to remove the defective stapler; this resulted in a laceration of the patient¿s sigmoid colon.Surgeon repaired the defect with sutures.The surgery was completed without further issue.
Additional Manufacturer Narrative
(b)(4).Date sent 10/1/2024.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 manufacturing date is currently not available.Therefore, the full udi is currently not available.Investigation summary: 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.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.Additional information was requested, and the following was obtained: could you please clarify if there were any patient consequences? could you please clarify if there were any change in the post-operative care of the patient as a result of the event? 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.

• Brand Name: CONTOUR CURVED CUTTER STAPLER
• 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 20343789
• Report Number: 3005075853-2024-07387
• Device Sequence Number: 15469401
• Product Code: GDW
• UDI-Device Identifier: 10705036012399
• UDI-Public: 10705036012399
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CS40B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 10/01/2024
• 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
• Patient Age: 69 YR
• Patient Sex: Unknown