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Catalog Number PLE60A
Device Problem Failure to Form Staple (2579)
Patient Problem Surgical procedure (2357)
Event Date 03/26/2013
Event Type  Injury  
Manufacturer Narrative
(b)(4). Additional information from rep: something i did talk to dr. And the pa about was how on the first firing of either gun the peri strips had been sitting in the gun for 10-15 minutes (the scrub tech would load the peri strips into the gun as a part of setting up the case). We talked about how on subsequent firings the "glue" that holds the strip in place will ooze out of the side of the gun, but when it's been sitting for a few minutes, or 10, it can harden up. They could see this being a potential hole in the swiss cheese model that we could eliminate. We decided that from now on the scrub tech will hold off on prepping the peri strips until the surgeon is almost done taking down the greater curve per the rep: -swiss cheese - this was not a part of my actual report, but i did use the analogy when talking with dr. - it refers to the idea that for a mishap to occur, several layers of "holes" have to line up, and if we can prevent just one of those "holes" (think pieces of swiss cheese lining up next to each other) from lining up we can prevent a mishap. There are no photos available. The cartridge was anvil side down when firing. This was the first firing on a sleeve gastrectomy case - there was no other staple or clip in the patient when this device was fired. There were no unexpected noises heard. None of the forces were higher or lower than expected, it was about as expected (expected high degree of force this close to the pylorus on the first firing of the stomach). After use each of the triggers and buttons returned to their original pre-fired positions without intervention. At the conclusion of the case the patient was expected to have a full recovery, the case was converted to bypass and completed. The analysis found that one pse60a device was returned in good visual condition and with one cartridge reload present. The reload was received fully fired and without damage on the cartridge deck. The device was tested for functionality in the straight position with a test cartridge reload and achieved its complete firing sequence without any difficulties. The staple line and cut line were complete and the staples were noted to have the proper b-form shape. In addition the returned reload was disassembled to verify the condition of the internal components and no anomalies were noted. The event could not be confirmed as no malformed staples were noted during functional testing. It should be noted that all devices are inspected 100% for staple presence by an automated vision system, and are visually inspected 100% as a final check. In addition, at finished goods the devices are visually inspected based on a sample.
Event Description
It was reported that during a laparoscopic sleeve gastrectomy, the device was loaded with a black cartridge and peri-strips were placed over the reload and the device was not fired for ten minutes. The device was fired for the first time over the stomach and the distal end on the patient's side was malformed. The row closest to the knife were semi-formed; approximately two centimeters. The two rows closest to the patient were not visible. A second and third gun was used to complete the case. The surgeon over-sewed over the malformed staples. The surgeon thought that there was too much tension after sewing over the malformed staples and was not confident in the sleeve and converted to a laparoscopic gastric bypass.
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Manufacturer (Section D)
475 calle c
guaynabo PR 0096 9
Manufacturer (Section G)
475 calle c
guaynabo PR 0096 9
Manufacturer Contact
kathy rice
4545 creek rd
cincinnati, OH 45242-2803
MDR Report Key3070327
MDR Text Key10727239
Report Number3005075853-2013-01886
Device Sequence Number1
Product Code GDW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/26/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2013
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/05/2018
Device Catalogue NumberPLE60A
Device Lot NumberK4C44F
Other Device ID NumberBATCH # K59E6E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2013
Is the Reporter a Health Professional? No
Date Manufacturer Received03/26/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/22/2013 Patient Sequence Number: 1