MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. POWERED 60 ECHELON +, 440MM SHAFT; STAPLE, IMPLANTABLE

Catalog Number PLEE60A

Device Problems Defective Component (2292); Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # n56a09.Device analysis: the analysis found that one plee60a device was returned with no apparent damage and with the manual override door out of position; the override lever was up which denotes that the knife was manually returned to home position.It should be noted after the manual override system is used the instrument is disabled and cannot be used for any subsequent firings.The bailout system was reset and then, the device was noted to be nonfunctional.In order to evaluate the condition of the internal components the device was disassembled.Upon disassembling, evidences of corrosion were noted on the motor.No functional testing could be performed due to the returned condition of the motor.One possible cause for this condition may be the exposure of cleaning solution.Please note that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure that the device meets the required specifications prior to shipment.The batch history record was reviewed and identified a defect/issue but was not related to the reported incident were found.In addition, no protocols or ncr related to the complaint, were found during the manufacturing process.

Event Description

Plee60a has been taken out from the packing with sterile technique.Surgeon has followed all the steps properly.Stapler gun was used with 2 gst60g and during 3rd firing with gst60b reload, stapler gun did not get fire.It worked for 2 firings only.Battery did not work; hence surgeon have completed surgery with other stapler.

• Brand Name: POWERED 60 ECHELON +, 440MM SHAFT
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7650570
• MDR Text Key: 113185594
• Report Number: 3005075853-2018-11036
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20705036014611
• UDI-Public: 20705036014611
• Combination Product (y/n): N
• PMA/PMN Number: K110385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2018

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 Expiration Date: 08/31/2019
• Device Catalogue Number: PLEE60A
• Device Lot Number: N92P6J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1