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

Catalog Number PSEE60A

Device Problems Failure to Advance (2524); Failure to Form Staple (2579); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch unknown.A manufacturing record evaluation was performed for the finished device and no non-conformances were identified.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.Additional information received: there were 2 staplers used during the procedure.The first was a psee60a with a white load, which was fired across the renal pedicle to ligate the vessels during a robotic nephrectomy.I was called to the room when the instrument advanced part way and stopped.I instructed the pa to activate the reverse button and open the stapler.The surgical tech showed me the damage to the anvil.The drivers were deployed almost the same distance in both reloads.My first thought was there must be a stent or something hard in the pedicle, but the dr.Had not trouble suturing the tissue or cutting it with scissors.Investigation summary: one photo was provided.The photo shows an anvil of a device with no reload loaded.The knife slot can be seen damaged.Based on the condition observed on the anvil, the event describe is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.

Event Description

It was reported that during a robotic nephrectomy, device was fired across the renal hilum and the stapler stopped and would not advance.It jammed up.The staples and the anvil were malformed.Another device was then pulled to complete the case but also stopped part way and would not advance.The staples and the anvil were malformed.Case completed by suturing the vessels with the robot.There were no patient consequences reported.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: the analysis results found that one psee60a device was returned with the anvil bent upwards and with a gst60w reload loaded on the device.The reload was received partially fired 2/3 with dents in some pockets.In addition, the cartridge was disassembled to verify the condition of the internal components and no anomalies were found.Furthermore, the anvil knife slot was noted to be damaged.No functional test was performed due the condition.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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances related to the reported complaint condition were identified.

Manufacturer Narrative

(b)(4).Investigation summary: the analysis results found that one psee60a device was returned with the anvil bent upwards and with a gst60w reload loaded on the device.The reload was received partially fired 2/3.Furthermore the anvil knife slot was noted to be damaged.No functional test was performed due the condition.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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances related to the reported complaint condition were identified.

• 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: 8693810
• MDR Text Key: 148027515
• Report Number: 3005075853-2019-19666
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2019

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: 04/30/2022
• Device Catalogue Number: PSEE60A
• Device Lot Number: T93583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/12/2019
• Supplement Dates Manufacturer Received: 06/13/2019; 06/25/2019
• Supplement Dates FDA Received: 06/20/2019; 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1