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

Model Number CS40G

Device Problems Defective Component (2292); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # t5e67w.User facility: (b)4).Additional information received: how did the device "misfire"? was the device unable to be fired (meaning no staple line or cut line was delivered)? if not, please provide further detail of how the device misfired.Response: the stapler simply did not fire.No staple line or cut line was delivered once the surgeon fired the stapler.Device analysis: the analysis results showed that the cs40g device was received with no apparent damage and with a reload loaded in the device.The reload was received fully loaded with staples, with the washer uncut, with the drivers and with the knife recess below the reload deck.The reload was not properly loaded in the device, as the retaining pin was not connected to the coupler and pushrod.These facts indicate that the reload was removed and reinserted incorrectly and/or incompletely after the retainer was removed.The returned reload was pulled out of the device and placed back on; the device opened and closed without any difficulties.The device was tested for functionality with the returned reload and it 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.It should be noted that if the reload is removed from the device, whether the reload is spent or not, and if the staple retainer has already been removed from the reload, the reload cannot be reloaded into the device.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.(b)(4).

• Brand Name: CONTOUR CURVED CUTTER STAPLER
• Type of Device: 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 9615818
• MDR Text Key: 180808987
• Report Number: 3005075853-2020-00504
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036012405
• UDI-Public: 10705036012405
• Combination Product (y/n): N
• PMA/PMN Number: K040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial
• Report Date: 11/26/2019

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
• Device Operator: No Information
• Device Model Number: CS40G
• Device Catalogue Number: CS40G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Manufacturer Received: 01/21/2020
• Initial Date FDA Received: 01/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 46 YR