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

Catalog Number CS40G

Device Problems Use of Device Problem (1670); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # n53m9z.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 a received void of staples, with the washer uncut and with the knife recessed below the reload deck.The drivers were noted to be partially advanced; 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.It should be noted that all devices are inspected 100% for staple presence by an automated vision system.In addition, at finished goods the devices are visually inspected based on a sample.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported that during a radical resection of the lower rectal carcinoma procedure, the surgeon found some staples protruding before firing.Another competitor's product was used to complete the procedure.There was no adverse consequence for the patient reported.

• Brand Name: CONTOUR CURVED CUTTER STAPLER
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 6070170
• MDR Text Key: 59065609
• Report Number: 3005075853-2016-06222
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2021
• Device Catalogue Number: CS40G
• Device Lot Number: N90J53
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2016
• 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