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

Model Number PSEE60A

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #t5em3r.Investigation summary: the analysis found that one psee60a device was returned with no apparent damage, and with one ecr60d cartridge loaded in the device.The cartridge 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 tested for functionality in the straight position with a test cartridge reload, and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples met the staple release criteria.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance were identified.The event described could not be confirmed as the device performed as intended and it opened and closed without any difficulties noted.

Event Description

It was reported that during a bullectomy, the device jaws adhered to the tissue and did not come off after the firing on the lung parenchyma.Neoveil sheet was used together at the firing.The manual override lever was used, but the issue was not resolved.Then, another device was used to cut the specimen additionally, and the specimen was removed from the patient.Meanwhile, the jaws came off the tissue, and the complaint product also could be removed from the trocar.There were no adverse consequences to the patient.No further information is available.

• Brand Name: POWERED 60 ECHELON +, 340MM 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: 9746037
• MDR Text Key: 200242236
• Report Number: 3005075853-2020-01199
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014607
• UDI-Public: 10705036014607
• 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: 01/27/2020

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: 10/15/2022
• Device Model Number: PSEE60A
• Device Catalogue Number: PSEE60A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1