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

Model Number PLEE60A

Device Problems Failure to Deliver (2338); Misfire (2532); Failure to Form Staple (2579); Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #u5ad4k.Investigation summary: the analysis found that one plee60a device was returned with no apparent damage and with no reload present.During further evaluation, the device was noted to be non-functional.In order to evaluate the condition of the internal components, the device was disassembled.Upon disassembly, evidence of corrosion was noted on the motor.No functional testing could be performed due to the returned condition of the motor.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance were identified.One possible cause for this condition may be the exposure of cleaning solution.Please reference the instruction for use for more information.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Complaint information will be included in complaint trending that is reviewed on a regular basis to determine if further action is necessary.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a roux-en-y procedure, the device misfired.It did not cut or deliver any staples.The device was tried a second time and it would not fire at all.There was no difficulty opening either device.The procedure was completed with a like device with no patient consequences.

• Brand Name: POWERED 60 ECHELON +, 440MM SHAFT
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10480419
• MDR Text Key: 206385984
• Report Number: 3005075853-2020-04457
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014614
• UDI-Public: 10705036014614
• Combination Product (y/n): N
• PMA/PMN Number: K110385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2023
• Device Model Number: PLEE60A
• Device Catalogue Number: PLEE60A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Date Manufacturer Received: 08/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1