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

Catalog Number CS40G

Device Problem Failure to Deliver (2338)

Patient Problems Sepsis (2067); No Code Available (3191)

Event Date 01/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # j5jc0z.Additional information was requested and the following was obtained: did the patient experience any bleeding? unknown if so, how much blood was lost? unknown.What intervention was done to control the bleeding? suturing/ hemostats.Did the patient require a blood transfusion? unknown.What type of medical intervention was conducted for the sepsis? the stapler was used & needed to perform anastomosis.Was there any change in the patient¿s post-op care? unknown.What is the current patient status? surgeon used alternative methods to perform satisfactory clinical outcome.What were the indications for surgery? mesorectal tumor.Was the transection done in one or multiple firings? one as it was a contour in use.What is meant by ¿did not deliver a full load of staples¿? it seems the reload were not fully loaded with staples as a full staple line did not delivered.Was the proximal line complete? was the distal line complete? scrub nurse can't remember.However, what she can remember is that they had to suture multiple spots and used x10 pds sutures to complete the anastomoses.What was done to address the incomplete staple line intra-operatively? pds sutures were used.Was the patient diverted or were they anastomosed with a circular stapler? anastomoses was partially achieved with the contour linear stapler with continuation of pds sutures.How long after initial procedure was the leak/bleed identified? surgeon tested leak and no leak presented before completion of surgery but a colostomy was positioned as preventative measures.Could the location of the leak/bleed be identified and how was it treated? suturing with colostomy as preventative measures.What is the current patient status? unknown at this time.Attempts are being to obtain additional information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please clarify if there was any additional medical intervention related to the sepsis.The analysis results showed that the cs40g device was received in good visual conditions and with a cartridge reload loaded in the device.The reload was received void of staples, with the washer completely cut, with the drivers exposed and with the knife recess below the cartridge deck.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.A batch record review was performed and no anomalies were found during the manufacturing process.

Event Description

It was reported that during a lower anterior resection procedure, the surgeon stated that the device did not deliver a full load of staples.It is unknown how the case was completed.Insufficient hemostasis with subsequent sepsis as a secondary complication.

Manufacturer Narrative

(b)(4).Please clarify if there was any additional medical intervention related to the sepsis.No sepsis presented as a subsequent secondary complication.Insufficient hemostasis was corrected by suturing.Preventative measures were taken to prevent sepsis.

• 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: 5419085
• MDR Text Key: 37780687
• Report Number: 3005075853-2016-00863
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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,Followup
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2017
• Device Catalogue Number: CS40G
• Device Lot Number: J4CF7N
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/08/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/03/2012
• 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
• Patient Outcome(s): Required Intervention