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

Catalog Number CS40B

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 05/19/2015

Event Type  malfunction  

Event Description

It was reported that prior to a colectomy procedure, the surgeon reported the device was "defective." this device was never used on the patient.The case was completed with another device of the same product code.There were no patient consequences reported.

Manufacturer Narrative

(b)(4) - incomplete firing cycle.The analysis results showed that the cs40b device was received in good visual conditions and with a reload loaded in the device.The reload was a received loaded with only (b)(4) staples present, with the washer uncut and with the knife recess below the reload deck.The staples were noted to be protruding; this condition is consistent with the device being partially activated.As a result of the partial firing the lockout was engaged when the device was reopened.Do not fire the instrument unless the closure trigger is properly latched against the handle.The firing trigger must be pulled back completely against the closure trigger to properly fire the instrument.In addition if the firing sequence is not complete, you could deploy the staples without cutting the washer and forming the staples.Please reference instructions for use for additional information.The device was tested for functionality with a test reload and the device fired, forming all staples and cutting as intended.The cut line was complete and the staples were noted to have the proper b-formed shape.The device opened and closed without any difficulties.A batch record review was performed and the batch had no anomalies noted during the manufacturing process.

Manufacturer Narrative

(b)(4).Additional information received: the clamp or device on the end would not properly open and close.Doctor felt like this device wasn¿t safe to use on the patient with the problems that they were encountering.I have the nurse/tech¿s statement.The peg wouldn¿t drop and after several attempts it dropped but wouldn¿t try.They decided that this couldn¿t be used and just got another one which operated successful.There was no harm to the patient.If more information is needed please let us know.

• Brand Name: CURVED CUTTER STAPLER
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: milton garrett ; 5133378865
• MDR Report Key: 4856713
• MDR Text Key: 5874148
• Report Number: 3005075853-2015-03777
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/03/2015

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: Health Professional
• Device Expiration Date: 05/11/2017
• Device Catalogue Number: CS40B
• Device Lot Number: J4AW1G
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/18/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 06/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/11/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1