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

Model Number EGIATRS60AXT

Device Problem Misfire (2532)

Patient Problem Tissue Damage (2104)

Event Date 11/14/2016

Event Type  Injury  

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, involving the stomach, the reload only fired part way and stopped and locked out with the powered stapler.A new reload was used and fired completely.The last known patient status is fine.There was unanticipated tissue loss as a result of this problem.

Manufacturer Narrative

(b)(4).Additional information: describe event or problem.

Event Description

Per additional information received, according to the reporter, they had to staple around the first staple line.They were able to finally release it from the tissue.

Manufacturer Narrative

(b)(4).Stapler handle was not returned.

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation of two devices visual inspection of the reloads noted that both were partially fired.Functional evaluation noted that one reload had a deformed anvil clamping mechanism.Both reloads fired all remaining staples without issue.Product analysis suggests the product was used in a surgical procedure.Replication of the deformed anvil clamping mechanism may occur when the application is over tissue that is beyond the recommended thickness range or when application with an obstacle incorporated in the jaws.In any of these circumstances, it will become increasingly difficult to actuate the firing handle and the instrument return knobs will be difficult to retract.In addition, staples may not form properly and tissue may not be fully transected.The information booklet which accompanies each product shipment offers the following as a warning and precaution-preoperative radiotherapy may result in changes to tissue.These changes may, for example, cause the tissue thickness to exceed the indicated range thickness for the staple size.Careful consideration should be given to any pre-surgical treatment the patient may have undergone and in corresponding selection of staple size.A review of the device history record indicates this devices lot number was released meeting all quality release specifications at the time of manufacture.No enhancements or improvements were generated for the reported condition.The product analysis concluded there were no device abnormalities that would have caused or contributed to the reported incident.Should new information become available, the file will be re-opened and reassessed at that time.

• 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, CT 06473 ; 2034925267
• MDR Report Key: 6159432
• MDR Text Key: 61920987
• Report Number: 1219930-2016-01321
• 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,Followup,Followup
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EGIATRS60AXT
• Device Catalogue Number: EGIATRS60AXT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: STAPLE, IMPLANTABLE
• Patient Outcome(s): Required Intervention