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

Model Number PCEE60A

Device Problems Crack (1135); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # t5er4c.Investigation summary: the analysis results found that one pcee60a device was returned with the anvil bent upwards with a gst60g reload loaded on the device.The reload was received fully fired with the cartridge deck damaged.Furthermore, the anvil knife slot was noted to be damaged.No functional test was performed due the condition.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance were identified.It is possible that the combination of tissue and/or buttressing material compressed between the device jaws may have been beyond indicated thickness or tissue that cannot compress to the indicated range for the selected cartridge.This may have caused excessive force to be applied to the underside of the solid steel anvil, leading to this damage.It should be noted that a 100% inspection takes place during manufacturing to ensure the device meets the required specifications prior to shipments, in addition, a sample of the batch is inspected at fgqa.Additional information was requested and the following was received: was the device locked on tissue with the jaws closed? no further information is available.If yes, how was the device removed? what troubleshooting steps were attempted to open the device (e.G.Squeezing the closing trigger while simultaneously depressing the anvil release button, knife reverse switch, manual override)? no further information is available.Did the jaws eventually open? no further information is available.

Event Description

It was reported that during a thoracoscopic pneumonectomy, the jaws of the pcee60a did not open after the third firing on the lung.The articulated shaft did not return to straight, so that the tip of the tt012 was cracked when removing the pcee60a from the patient through the tt012.No pieces were left inside the patient.The deployed staples were formed as intended.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• 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: 9825721
• MDR Text Key: 200614087
• Report Number: 3005075853-2020-01553
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036015017
• UDI-Public: 10705036015017
• 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: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: PCEE60A
• Device Catalogue Number: PCEE60A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Date Manufacturer Received: 02/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1