MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON ENDO GIA* TRI-STAPLE RR 60MM M/T RELOAD; MESH, SURGICAL, DEPLOYER

Model Number EGIATRS60AMT

Device Problem Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional attempts to obtain information and the device have been made.A supplemental report will be submitted with new details if they become available.

Event Description

According to the reporter, during a laparoscopic sleeve gastrectomy the stapler laid down 10mm of staples and stopped.Surgeon was unable to advance it further.He re-tracked the stapling mechanism and cut the buttress material in order to remove the stapler.The staple line was completed successfully with another device.Current patient status is good.Ended colostomy, formal laparotomy, re-operation etc.There was no unanticipated tissue loss.There was no irreversible tissue damage.There was no unanticipated extension of the incision by more than one inch.There was no unanticipated blood loss of 500cc or more.Surgery time was not delayed by more than 30 minutes.No device fragment or component fell into the patient's cavity.There was no device fragment left in patient's cavity.Additional information requested via email to (b)(4).Can you confirm that product is available and will be returned for evaluation? please provide the serial number and product id of the idrive handle used.Could you please provide the udi# (see attached, red box) for the handle used in the procedure? please provide the serial number and product id of the idrive adapter used.What is the udi# for the adapter used in the procedure? what was the device sterilization method? (eto or autoclave).(1).What type of cleaning was used on this device? (manual or auto-washer).Please describe the status of the following lights: (1).Status indicators: (2).5 white lights: (3).Handle indicator: (4).Adapter indicator: (5).Reload indicator: what is the lot number for the reload used with this stapler? could you please provide the udi# (see attached, red box) for the reload used in the procedure? should the customer(s) be notified of product analysis results, if available? (customer response letter).

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the cartridge revealed that the reload was partially fired to the 3.5cm line.Microscopic evaluation noted that the reload had damage to the cutting edge of the knife blade.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Replication of the damaged knife blade may occur when an obstacle has been incorporated in the jaws during application.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

• Type of Device: MESH, SURGICAL, DEPLOYER
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven 06473 ; 2034925267
• MDR Report Key: 6190142
• MDR Text Key: 62858406
• Report Number: 1219930-2016-01381
• Device Sequence Number: 1
• Product Code: ORQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EGIATRS60AMT
• Device Catalogue Number: EGIATRS60AMT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1