MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC.; STAPLE, IMPLANTABLE

Catalog Number PSEE60A

Device Problems Sticking (1597); Difficult to Open or Close (2921); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information requested and received: on the firings with the opening issue, where in the firing sequence did the devices jam (safety lock-out, partially fire, during automatic knife return, etc.)? please clarify for both devices.Partial fire.Did the manual override work to open the second device? yes, both devices.If no, how was the device removed from the tissue? did the jaws eventually open to release the tissue? yes.Additional information received: seems if it was too hard to close, might have been their #1 indication.Imagine it would have been a pretty tight snap in each event.I did ask the tech about what they saw in each event.I know the nephrectomy case was extremely thick tissue because they wanted to use a cov ultra gun, but it wouldn't even take the bite.The analysis results found that one psee60a device was returned with the anvil bent upwards and without a reload loaded on the device.Furthermore, the anvil knife slot was noted to be damaged.It is possible that the combination of tissue and/or buttressing material compressed between the device jaws may have been beyond indicated thickness or tissue that cannot compress to the indicated range for the selected cartridge.This may have caused excessive force to be applied to the underside of the solid steel anvil leading to this damage.It should be noted that a 100% inspections takes place during manufacturing to ensure the device meets the required specifications prior to shipments, in addition, a sample of the batch is inspected at fgqa.The device history records were reviewed and the manufacturing criteria were met prior to the release of this batch/lot.

Event Description

It was reported by the sales rep that during an open simple nephrectomy procedure, the circulator called to state that surgeon was stuck on tissue.Was using gst60g reloads on thick kidney tissue.When i called back into room, they had used manual override to release device.They had one reload that worked and one that did not.They opened a new stapler, same event occurred a second time, fired once, jammed once.They said they tried using the reverse switch on both devices and it did not work either time.Nurse did describe tissue as being very thick.Says that three techs and two surgeons were not able to get device opened.Another like device was used to complete the procedure.There were no adverse consequences for the patient.

Manufacturer Narrative

(b)(4).Date sent: 6/5/2017.Photographic analysis: five pictures were provided.An anvil reversed camber, with the anvil knife slot damaged can be appreciated on the pictures.It is possible that the combination of tissue and/or buttressing material compressed between the device jaws may have been beyond indicated thickness or tissue that cannot compress to the indicated range for the selected cartridge.This may have caused excessive force to be applied to the underside of the solid steel anvil leading to this damage.Based on the photos alone the event describe is confirmed, unfortunately there is not enough evidence in the photos to determine root cause.Please refer to the device analysis for full analysis details and conclusion.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• 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: 6581371
• MDR Text Key: 75832092
• Report Number: 3005075853-2017-02680
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2020
• Device Catalogue Number: PSEE60A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/03/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/24/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1