MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD ECH FLEX 60MM 34CM SHAFT; STAPLE, IMPLANTABLE

Catalog Number PSE60A

Device Problem Component Missing (2306)

Patient Problems Failure to Anastomose (1028); No Code Available (3191)

Event Date 01/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.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.On what firing of device did issue occur? after firing, were there any staples on the anastomotic site or cartridge? if so, describe shape.Does the surgeon routinely wait 15 seconds prior to firing? was the procedure a total or subtotal gastrectomy? what two structures were being anastomosed when issue occurred? is device or reload available for return? what is the current patient status?.

Event Description

It was reported that during the endoscopic surgery for gastric cancer, when did the anastomosis of jejunum with pse60a and ecr60w, after fired, noted no staple in the tissue, checked the reload and surgical view, also no staple.The cut line was complete and good.Changed to open surgery, used the suture to sew the anastomotic site, the surgery delayed about half hour.The patient is stable and in hospital now.

• Brand Name: PWRD ECH FLEX 60MM 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: 9144769
• MDR Text Key: 163311129
• Report Number: 3005075853-2019-22499
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036014324
• UDI-Public: 10705036014324
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K110385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PSE60A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention