MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ENDO GIA; STAPLE, IMPLANTABLE

Model Number EGIATRS60AMT

Device Problem Separation Failure (2547)

Patient Problem No Code Available (3191)

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during an open lung resection, when the stapler was fired across lung tissue, there was a poor staple formation.Staple load was removed and reinforcement was hanging off of the distal tip of the reload and seemed to be ¿bunched-up¿ at the end.One side of the stapled tissue area had staples, while the other did not.All of the buttress material remained on the reload after firing.The load was dipped in sterile water prior to firing per ifu.In order to complete the case and resolve the issue, suture was used to sew over the area where the stapler was fired.No patient injury was noted but the surgical time was extended to greater than 30 minutes to re-suture the area.

Manufacturer Narrative

The incident device has been received and is still under evaluation.When the device evaluation is complete, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis summary: post market vigilance (pmv) received one reload opened by the account without the packaging.The product expiration date cannot be verified as the lot # was not reported.Visual inspection of the returned product noted that the reload was fully fired.The suture on the distal cartridge side was still secured.Torn trs material was noted under the distal cartridge suture.Pmv fired the device to the 0cm cut line in an attempt to disengage the still secure suture.The suture was still secure.Sent to engineering for further analysis.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the returned product noted that the reload was fully fired.The suture on the distal cartridge side was still secured.Torn trs material was noted under the distal cartridge suture.It was found that on one side of the jaw the staple pushers were flush while the rest of the staple pushers were fully advanced from the cartridge¿s surface.The flush pushers are evidence that either thick tissue was encountered on a portion of the firing or the buttress that ¿bunched¿ up increased the thickness in the jaws.It was found that the suture had deformed the cinch slot on the upper section ¿above¿ the living hinge nylon portion.This slight deformation of the slot caused the suture to release sideways out of the slot not fully disengaging.The living hinge mechanism functioned as intended by displacing the nylon fully outward to slide the suture out of the cinch slot.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the observed conditions can be caused by excessive manipulation of the reload during use which can cause the reinforcement material to tear and/or detach and through manipulation of tissue using the anvil side of the loading unit, or clamping over excessive thickness.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.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO GIA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6891907
• MDR Text Key: 87300000
• Report Number: 1219930-2017-07386
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2017
• Initial Date FDA Received: 09/25/2017
• Supplement Dates Manufacturer Received: 10/26/2017; 11/25/2017; 01/11/2018
• Supplement Dates FDA Received: 11/02/2017; 12/15/2017; 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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