MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD ECH FLEX 45MM 34CM SHAFT; STAPLE, IMPLANTABLE

Catalog Number PSE45A

Device Problems Break (1069); Retraction Problem (1536); Defective Component (2292); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 04/25/2018

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 device history records were reviewed and the manufacturing criteria were 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 was the indication for surgery? did the patient undergo preoperative radiation or chemo therapy? was the device difficult to close? what troubleshooting steps were taken to open the device? what color cartridge was used? what is the surgeon¿s experience with device? during the 2nd firing with pse45a, was a new cartridge used or attempted to fire with first cartridge again? with the contour device, was the closing trigger or firing trigger broken? was the transection of colon attempted to be completed with one or multiple firings of contour? how was the procedure completed? what is the current patient status?.

Event Description

It was reported that during a laparoscopic rectosigmoidectomy and deep endometriosis procedure, the surgeon reported that he made the assembly and the choice of the correct load for the manipulated tissue and that at the moment of firing of the endostapler the blade advanced little afterwards locking.The surgeon triggered the reverse button and as the blade did not return he had to trigger the safety system for manual return and opening the jaw of the stapler.It was requested a new endostapler and the same problem occurred.The surgeon reported that he had to make a phannenstiel incision exposing the part and requested a curved staple cutter contour cs40g and that it also showed defect at the moment of the firing by breaking the safety lock and the trigger.

• Brand Name: PWRD ECH FLEX 45MM 34CM SHAFT
• 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: 7526569
• MDR Text Key: 108668210
• Report Number: 3005075853-2018-09991
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20705036014314
• UDI-Public: 20705036014314
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K110385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2018

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: 11/30/2020
• Device Catalogue Number: PSE45A
• Device Lot Number: P94L3U
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/18/2018
• Date Device Manufactured: 12/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention