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

Catalog Number CS40G

Device Problem Failure to Deliver (2338)

Patient Problem No Code Available (3191)

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: how was the procedure completed? instead of anastomosis and ileostomy ¿ (b)(4) procedure.Were there any patient consequences? he received a discharged note.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Did the surgeon complete the distal transection in one or multiple firings? was the device difficult to close? were staples visible? if so, please describe the shape.Has the re-anastomosis been completed or scheduled? what is the current patient status?.

Event Description

It was reported that during a low anterior resection, during resection of the rectum, the device did not deliver any staples on tissue.The lumen of the rectum remained open, as the device cut but not delivered the staples.

Manufacturer Narrative

(b)(4).Batch # r57n1k.The analysis results showed that the cs40g 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 was complete, the staple line was complete, and the staples were noted to have the proper b-formed shape.The device lockout and the reload lockout were functional.The event described could not be confirmed as the device performed without any difficulties noted.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.Additional information was requested and the following was obtained: did the surgeon complete the distal transection in one or multiple firings? one firing.Was the device difficult to close? no.Were staples visible? if so, please describe the shape.No.Has the re-anastomosis been completed or scheduled? the re-anastomosis has been scheduled.What is the current patient status? the patient is receiving chemotherapy regimen.

• Brand Name: CONTOUR CURVED CUTTER STAPLER
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7731292
• MDR Text Key: 115376036
• Report Number: 3005075853-2018-11673
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20705036012402
• UDI-Public: 20705036012402
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: CS40G
• Device Lot Number: R92P30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Date Manufacturer Received: 08/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention