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

Catalog Number PSEE60A

Device Problems Crack (1135); Retraction Problem (1536); Difficult to Open or Close (2921); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem No Code Available (3191)

Event Date 05/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.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.The manufacturing record evaluation was performed, and the manufacturing criteria was met prior to the release of this batch/lot.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent.What were the indications for surgery? did the patient undergo any preoperative radiation or chemo therapy? does the surgeon routinely wait 15 seconds prior to firing? does the surgeon pulse fire or use one continuous firing stroke? what is the current patient status?.

Event Description

It was reported that during a vats right upper multiple wedge resection, a psee60a was used with multiple gst60g reloads.On the fourth or fifth firing the surgeon noticed that the power on the stapler was very slow.Surgeon was aware that it was thick tissue.The stapler did not return automatically.The surgeon used the reverse button and the stapler began to reverse the blade.However there was a ¿pop¿ sound and the device stopped.The blade was not completely reversed so the manual override was used.The lever would not ratchet freely and was very difficult to move.After a lot of pressure it cracked and then flowed easily but the blade would not come back and the stapler wouldn't open.A pcee45a stapler with a gst45g reload was opened to resect the psee60a stapler off the tissue.This stapler also stopped midway through the firing but the reverse did bring the blade back.Upon removal of the pcee45a the device was inspected and the anvil appears to be bent in the middle section.A second pcee45a was opened and fired with a gst45g reload.The psee60a stapler was then freed up and with a mini thoracotomy the specimen and stapler were removed.When the stapler came out of the trocar the anvil did open up on its own.Upon inspection of the psee60a anvil it also was bent in the middle section.

Manufacturer Narrative

(b)(4).Batch # r57a2n.Investigation summary: the analysis found that one psee60a device was returned with a trocar inserted on the shaft and with the anvil bent upwards and with an ecr60g reload not loaded on the device.The reload was received fully fired.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 subsequent firings.Furthermore, the anvil knife slot and joint cover were noted to be damaged.No functional test was performed due to 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.Reloads b, d, & g: gst45g, t5a481, fully fired.Reloads c & e: gst45g, t5a72p , fully fired.Reload f: gst45g, r5ag9k , fully fired.Reloads h & k: gst45g, p56r5m, fully fired.Reload j: gst45g, p55g4p , fully fired.Reload i: gst45g, p56r5m, partially fired 2/3.

Manufacturer Narrative

Product complaint # (b)(4).Additional information requested and received: what were the indications for surgery? unknown.Did the patient undergo any preoperative radiation or chemo therapy? unknown.Does the surgeon routinely wait 15 seconds prior to firing? yes.Does the surgeon pulse fire or use one continuous firing stroke? pulse fire on this case due to the thick tissue.But he does fire continuously as well.What is the current patient status? we met with the surgeon about 2 weeks after the procedure and he said the patient was doing well.

• 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: 8675625
• MDR Text Key: 147236178
• Report Number: 3005075853-2019-19502
• 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: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: PSEE60A
• Device Lot Number: R92E9E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Initial Date Manufacturer Received: 05/08/2019
• Initial Date FDA Received: 06/06/2019
• Supplement Dates Manufacturer Received: 06/06/2019; 08/01/2019
• Supplement Dates FDA Received: 07/02/2019; 08/29/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention