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

Catalog Number PCEE60A

Device Problems Crack (1135); Retraction Problem (1536); Detachment of Device or Device Component (2907); Noise, Audible (3273); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Batch # unk.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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.

Event Description

It was reported that during an open urinary diversion at the bladder total extirpation, an unexpected sound was heard, and the device slightly moved forward and stopped at the proximal end of the cartridge at the first firing.The device was used on the dorsal vein complex with the shaft was articulated.Angle of the articulation was unknown.Then, the surgeon grasped the firing trigger several times, the knife moved forward slightly again but stopped.The surgeon tried to use manual override lever to release the device, but the lever had a difficulty in moving.And then, the plastic part of the device fell off, and it was found that the manual override lever was cracked.Then, the sales rep entered the operation room and he found that the articulation functioned though the knife did not return.Also, it was found that the device clamped a balloon.After that, a forceps was used to apply the external force to the jaws to remove the balloon, and the device was removed from the patient.The staples at the middle and the distal end of the cartridge were not deployed.The knife reverse switch was not used.The cartridge color was black.An energy device was used on the dorsal vein complex, and another device (pcee60a) was used to complete the case.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Batch # r59062.The analysis found that one pcee60a device was returned with the anvil bent upwards and damaged knife slot area.The manual override door was noted to be 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 subsequence firings.A gst60t cartridge reload was received partially fired 1/2 and with the pan dislodged.Additionally the cartridge body and drivers were noted to be damaged and the knife was buckled.No functional test was performed due the condition of the device.The damage to the cartridge, knife and anvil is consistent with the device being clamped over an excess of tissue, causing the anvil to bent and for the firing stroke and the staple form to be incomplete.If the firing continues the knife will buckle, and as the knife is attempting to pull the anvil towards the cartridge to form the staples it will result in the damage observed on the anvil.A plastic piece received inside a plastic jar, the plastic piece belong to reverse lever.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Brand Name: POWERED 60 ECHELON +, 280MM SHAFT
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8005674
• MDR Text Key: 125305962
• Report Number: 3005075853-2018-13949
• 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
• Type of Report: Initial,Followup
• Report Date: 10/02/2018

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: 05/20/2021
• Device Catalogue Number: PCEE60A
• Device Lot Number: R93R32
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 10/25/2018
• Supplement Dates Manufacturer Received: 11/08/2018
• Supplement Dates FDA Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RELOAD - GST60T X 1