COVIDIEN CURVED STAPLER EGIAUSTND

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-27 for COVIDIEN CURVED STAPLER EGIAUSTND manufactured by Covidien.

MAUDE Entry Details

• Report Number: MW5089378
• MDR Report Key: 8939660
• Date Received: 2019-08-27
• Date of Report: 2019-08-22
• Date of Event: 2018-09-28
• Date Added to Maude: 2019-08-28
• 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: 0

Device Sequence Number: 1

• Brand Name: COVIDIEN CURVED STAPLER
• Generic Name: STAPLER, SURGICAL
• Product Code: GAG
• Date Received: 2019-08-27
• Model Number: EGIAUSTND
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COVIDIEN

Device Sequence Number: 2

• Brand Name: COVIDIEN CURVED STAPLER
• Generic Name: STAPLER, SURGICAL
• Product Code: GAG
• Date Received: 2019-08-27
• Model Number: EGIAUXL
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: COVIDIEN

Device Sequence Number: 3

• Brand Name: COVIDIEN CURVED STAPLER
• Generic Name: STAPLER, SURGICAL
• Product Code: GAG
• Date Received: 2019-08-27
• Model Number: EGIAUSHORT
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: COVIDIEN

Device Sequence Number: 4

• Brand Name: COVIDIEN CURVED STAPLER
• Generic Name: STAPLER, SURGICAL
• Product Code: GAG
• Date Received: 2019-08-27
• Model Number: SIGRADXT
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: COVIDIEN

Device Sequence Number: 5

• Brand Name: COVIDIEN CURVED STAPLER
• Generic Name: STAPLER, SURGICAL
• Product Code: GAG
• Date Received: 2019-08-27
• Model Number: SIGRADMT
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: COVIDIEN

Device Sequence Number: 6

• Brand Name: STAPLER
• Generic Name: STAPLER, SURGICAL
• Product Code: GAG
• Date Received: 2019-08-27
• Model Number: TLC75
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 6
• Device Event Key: 0
• Manufacturer: ETHICON ENDO-SURGERY, INC.

Device Sequence Number: 7

• Brand Name: COVIDIEN CURVED STAPLER
• Generic Name: STAPLER, SURGICAL
• Product Code: GAG
• Date Received: 2019-08-27
• Model Number: EEA31
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 7
• Device Event Key: 0
• Manufacturer: COVIDIEN

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Other	2019-08-27