MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC.; STAPLE, IMPLANTABLE

Catalog Number PLE60A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Blood Loss (2597)

Event Type  Death  

Manufacturer Narrative

(b)(4) date sent: 6/28/2016 batch # unk additional information received: procedures: bypass ¿ some sleeve stapler: powered 1st generation ple60a ¿ pse60a reloads: ecr blue on the stomach ¿ white on bowel.Additional information requested but unavailable: what was the surgical procedure? was there any issues noted with stapler performance during procedure? was buttressing material used? what does the surgeon believe was the cause of the bleeding? is an autopsy report available?.

Event Description

It was reported that following an unknown procedure, the patient experienced post-operative bleeding.Patient couldn't be operated quick enough due to a late management of this post operative bleeding by the night team.Exact procedure date wasn't mentioned, probably around (b)(6) 2014.

Manufacturer Narrative

(b)(4).Date sent: 7/26/2016.Additional information was requested and the following was obtained: what does the surgeon believe was the cause of the bleeding? staple line bleeding.Is an autopsy report available? no.

Manufacturer Narrative

(b)(4).Additional information requested and received: what was the surgical procedure - bypass.Was there any issues noted with stapler performance during procedure - no.Was buttressing material used - no.

• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5754621
• MDR Text Key: 48363043
• Report Number: 3005075853-2016-03635
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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,Followup,Followup
• Report Date: 06/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PLE60A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death