MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. POWERED 60 ECHELON +, 280MM SHAFT; STAPLE, IMPLANTABLE

Model Number PCEE60A

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # u5cl20.Investigation summary: the analysis found that one pcee60a device was returned with no apparent damage and with one reload loaded in the device.The reload was received fully fired.The manual override door was 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, it was tested for functionality in the straight position with a test reload and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples meet the staple release criteria.Batch records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.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 whipple procedure the physician requested a gray reload and was handed a black reload.He fired on the vessel and opened it up.The case was completed with no patient consequences.The physician stated the packaging for the reloads is confusing and should be marked clearer.

• Brand Name: POWERED 60 ECHELON +, 280MM 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: 10518538
• MDR Text Key: 206559944
• Report Number: 3005075853-2020-04596
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036015017
• UDI-Public: 10705036015017
• 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: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2020
• Device Model Number: PCEE60A
• Device Catalogue Number: PCEE60A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Date Manufacturer Received: 08/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1