MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. POWERED 60 ECHELON +, 340MM SHAFT; STAPLE, IMPLANTABLE

Catalog Number PSEE60A

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.Additional information requested and received: the event description states that it was pse60a and the impacted product submitted indicates a psee60a.Please confirm the product code.Yes, psee60a.Is the lot number available? no.Did the device lock-out (no staples deployed and no cut line started)? or, did the device start to deploy staples and cut but could not be completed (partially fire)? yes that is correct.Or, did the device fully fire and stop during the automatic knife return? was there any difficulty opening the device? yes.Device wasn¿t able to open.If yes, how was the device removed from the patient? information wasn¿t provided by staff when we probed the hospital staff and doctor.

Event Description

It was reported that during a thoractomy procedure that the pse60a locked on tissue during a resection of upper right lobe.No patient consequences reported.

• Brand Name: POWERED 60 ECHELON +, 340MM 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: 7651204
• MDR Text Key: 113006177
• Report Number: 3005075853-2018-11047
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20705036014604
• UDI-Public: 20705036014604
• 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
• Report Date: 06/06/2018

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 Catalogue Number: PSEE60A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1