MAUDE Adverse Event Report: COVIDIEN COVIDIEN CURVED STAPLER; STAPLER, SURGICAL

Model Number EGIAUSTND

Device Problems Break (1069); Misfire (2532)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2018

Event Type  Injury  

Event Description

Endo gi stapler used after rectal tumor removed.Gia stapler with curved purple loads that long enough.Stapler broke.Stapler misfire and / or broke.Egiaustnd, egiauxl, egiaushort, sigradxt, sigradmt, tlc75, eea31; 4 different staplers used with same outcome.

• Brand Name: COVIDIEN CURVED STAPLER
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 8939660
• MDR Text Key: 155990122
• Report Number: MW5089378
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/22/2019
• 7 Devices were Involved in the Event: 1 2 3 4 5 6 7

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: EGIAUSTND
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 44 YR
• Patient Weight: 66