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

Model Number PSEE60A

Device Problems Failure to Advance (2524); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # p5853d.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.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.

Event Description

It was reported that during a lobectomy with wedge resection, when using the third cartridge (gold), the blade didn't move forward and locked.The tissue was normal and not thick.Surgeon changed to a fourth cartridge and the blade didn't advance again.He changed to a powered echelon body (another psee60a) and it worked.When the sales rep checked the powered echelon body with another cartridge, it worked normally, but the battery was too hot even six hours after the surgery.There were no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 9/9/2020.Investigation summary: the analysis found that one psee60a device was returned with no apparent damage and with two gst60d (b & c) reloads present.The reloads were received partially fired 1/16.The returned device and reloads were tested for functionality in the straight position by resetting and reloading it into the device.The device achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the remaining staples met the staple form release criteria.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.It is possible that while loading the reload, the reload was pushed farther back than the reload alignment stop windows, resulting in the knife pushing the one piece sled forward and locking the reload.The battery pack has a drain feature that drains the pack within 24 hours of the procedure; therefore, testing cannot be completed on the original battery used in the procedure.As a result, product inquiries are tested with non-draining packs/simulators.Upon visual inspection of two photos, the following was observed: the photos show a gold reload from the pan side and the sled appears to be partially advanced.Based on the photos, the event described is confirmed, however, no conclusion or root cause could be determined.Please refer to the device analysis for full analysis details and conclusion.

• Brand Name: POWERED 60 ECHELON +, 340MM SHAFT
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10381993
• MDR Text Key: 203144240
• Report Number: 3005075853-2020-04024
• 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
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: PSEE60A
• Device Catalogue Number: PSEE60A
• Device Lot Number: U94341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Date Manufacturer Received: 08/10/2020
• Patient Sequence Number: 1
• Treatment: GST60D X2