MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. POWERED PLUS STANDARD 45; STAPLE, IMPLANTABLE

Catalog Number PSEE45A

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # t5al3f.Investigation summary: the analysis found that device was returned for analysis with no cartridge loaded on the device.The device was returned with a non-working firing mechanism.No further functional test could be performed due to the condition of the device.In order to verify the condition of the internal components, the device was disassembled.Upon disassembling, the switch actuator post was found to be broken leaving the switch actuator loose which lead the device not to fire.Although no conclusion could be reached as to how the device became damaged, it should be noted 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 device opened and closed without any difficulties noted.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Additional information requested and received: can you please describe the yellow bits in the reload? yellow bits looked like the retaining cap on the ecr45m reload.Found by the safety and the firing trigger of the proximal side of the handle.Are you referring to the staple retaining cap? yes.Did any of these yellow bits fall into the patient? no.

Event Description

It was reported during a laparoscopic appendectomy the device handle would not close fully while using a ecr45m reload.The tech also found yellow bits in the reload.A second like stapler and reload were used to complete the procedure with no patient consequences reported.

• Brand Name: POWERED PLUS STANDARD 45
• 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: 8717371
• MDR Text Key: 149800643
• Report Number: 3005075853-2019-19893
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036015352
• UDI-Public: 10705036015352
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/28/2019

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: 02/02/2022
• Device Catalogue Number: PSEE45A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/20/2019
• Date Device Manufactured: 03/02/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1