MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. POWERED PLUS COMPACT 45; STAPLE, IMPLANTABLE

Catalog Number PCEE45A

Device Problem Failure to Advance (2524)

Patient Problem Blood Loss (2597)

Event Date 04/26/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Batch # r5at4p.Investigation summary: the analysis found that one pcee45a device was returned with no apparent damage and with a gst45w partially fired 1/10 cartridge not loaded on the device.The device was 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 were noted to have the proper b-form shape.It is possible that while loading the reload, the cartridge was pushed farther back than the cartridge alignment stop windows resulting in the knife pushing the one piece sled forward and locking the cartridge.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Additional information requested and received: what were the indications for surgery? i don¿t know.Please confirm vessel being fired on.Ivx.Was the power reverse button or the manual override used? power reverse.Did the device deliver any staples? no.Was the device difficult to open? i dont know.Were any unusual noises heard? no.Does the surgeon routinely wait 15 seconds prior to firing? yes.Was a blood transfusion required? i dont know.What is the current patient status? unknown.

Event Description

It was reported that during a hepatectomy procedure, on the eighth firing of the stapler, with a white reload, no buttressing material, the doctor fired the stapler across the vena cava and was unable to advance the stapler or complete the firing sequence.Blood loss occurred, approximately 4000 cc and bleeding was controlled using suture.It was not reported if blood products or a blood transfusion was required.The procedure was completed without the use of any additional devices.The patient is doing fine.

• Brand Name: POWERED PLUS COMPACT 45
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8627501
• MDR Text Key: 145633719
• Report Number: 3005075853-2019-19258
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036015338
• UDI-Public: 10705036015338
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2019

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: 10/31/2021
• Device Catalogue Number: PCEE45A
• Device Lot Number: R9536W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/21/2019
• Date Device Manufactured: 11/14/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention