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

Catalog Number CS40B

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # t5cj36.Additional information was requested, and the following was obtained: were there any patient consequences? the patient outcome is unknown at this time.They will investigate the incident and reply when information becomes available.Device analysis: the analysis results showed that the cs40b device was received with no apparent damage and with no reload present.The device was tested for functionality with an engineering sample reload and the device fired, forming all staples and cutting as intended.The cut line and the staple line were completed and the staples meet the staple form release criteria.The device lockout and the reload lockout were functional.The event described could not be confirmed as the device performed without any difficulties noted and no cartridge was returned for analysis.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Event Description

It was reported that the surgeon fired the device and claims that the device cut, but no staples ejected whatsoever.He was unable to locate staples in the area where the staple line would normally be, nor was able to identify staples anywhere inside the patient either.Therefore, he concluded that the load did not contain staples to begin with.Surgeon stated that he used sutures to close the cut tissue and successfully completed the procedure.Unknown if this caused and consequences to the patient.

• Brand Name: CONTOUR CURVED CUTTER STAPLER
• Type of Device: 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: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 9086694
• MDR Text Key: 195106308
• Report Number: 3005075853-2019-22204
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036012399
• UDI-Public: 10705036012399
• Combination Product (y/n): N
• PMA/PMN Number: K040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2024
• Device Catalogue Number: CS40B
• Device Lot Number: T93D1N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Date Manufacturer Received: 08/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1