STAPLER ENDOSCOPIC 33 MM T1 LINEAR CUTTER CIRCULAR EEA33

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for STAPLER ENDOSCOPIC 33 MM T1 LINEAR CUTTER CIRCULAR EEA33 manufactured by Covidien.

Event Text Entries

[184665003] Pt was admitted for surgery (b)(6) 2019 with dx rectal ca. He was readmitted (b)(6) 2019 due to rectal pain. Op findings from (b)(6) 2019 include "rectal examination revealed findings consistent with an anastomotic dehiscence, with contaminant within the presacral space, presacral pelvic abscess" which qualifies this case as a surgical site infection (organ/space of the gi tract). Fda safety report id#s (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093869
• MDR Report Key: 9865162
• Date Received: 2020-03-20
• Date of Report: 2020-03-18
• Date of Event: 2019-10-18
• Date Added to Maude: 2020-03-23
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: STAPLER ENDOSCOPIC 33 MM T1 LINEAR CUTTER CIRCULAR
• Generic Name: STAPLER, SURGICAL
• Product Code: GAG
• Date Received: 2020-03-20
• Model Number: EEA33
• Lot Number: 278878
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COVIDIEN

Device Sequence Number: 2

• Brand Name: HANDLE STAPLER STANDARD ENDO GIA ULTRA 4
• Generic Name: STAPLER, SURGICAL
• Product Code: GAG
• Date Received: 2020-03-20
• Model Number: EGIAUSTND
• Lot Number: 287295
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: COVIDIEN

Device Sequence Number: 3

• Brand Name: CURVED STAPLER
• Generic Name: STAPLER, SURGICAL
• Product Code: GAG
• Date Received: 2020-03-20
• Catalog Number: 3400
• Lot Number: 3400
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: COVIDIEN

Device Sequence Number: 4

• Brand Name: LINER STAPLE
• Generic Name: STAPLE, IMPLANTABLE
• Product Code: GDW
• Date Received: 2020-03-20
• Lot Number: 3400
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: COVIDIEN

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention	2020-03-20