MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD ECH FLEX 60MM 44CM SHAFT; STAPLE, IMPLANTABLE

Catalog Number	PLE60A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 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.Did the safety lockout engage (no staples or a cut line delivered beyond the lockout)? if staples deployed into tissue where they formed in the proper closed b-formation? was the device locked on tissue with the jaws closed? did the jaws eventually open? will the device be returned for analysis?.
Event or Problem Description
After the third shot the stapler locked, the reverse did not work.They opened a new stapler and continued the surgery.There was no harm to the patient.No further descriptions of the event.Procedure: laparoscopic radical cistectomy.
Additional Manufacturer Narrative
(b)(4).Mdr decision: not reportable.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event, and has been revised to not reportable.Did the safety lockout engage (no staples or a cut line delivered beyond the lockout)? i do not have more information.If staples deployed into tissue were they formed in the proper closed b-formation? yes.Was the device locked on tissue with the jaws closed? yes.Did the jaws eventually open? yes.Will the device be returned for analysis? yes.

• Brand Name: PWRD ECH FLEX 60MM 44CM SHAFT
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8174218
• Report Number: 3005075853-2018-15209
• Device Sequence Number: 2035756
• Product Code: GDW
• UDI-Device Identifier: 10705036014300
• UDI-Public: 10705036014300
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K110385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: PLE60A
• Device Lot Number: R92Z70
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/14/2019
• Patient Sequence Number: 1