MAUDE Adverse Event Report: COVIDIEN GIA ENDO STAPLER 33.5

Model Number 33.5

Device Problem Failure to Advance (2524)

Patient Problems Nerve Damage (1979); Pain (1994)

Event Date 11/27/2015

Event Type  Injury  

Event Description

Was scheduled to have a laparoscopic appendectomy at (b)(6) medical center in (b)(6) after a trip to the er.During the surgery the covidien endo gia stapler clamped and wouldn't release, i may now have nerve damage due to this as i am experiencing additional pain symptoms and other issues since this surgery.After converting to open appendectomy additional attempts were made to release the device unsuccessfully.Hospital ceo stated parts were disposable and that maintenance was never done on this machine including no calibration to it.I was barely offered an apology after this event.Have no idea if the hospital or manufacture has reported this incident.Will also be reporting this to the ma department of public health as i am not sure if it was the hospital's fault for not properly inspecting equipment, if it was the fault of the surgeon or a defect in the manufacturing.

• Brand Name: GIA ENDO STAPLER 33.5
• Type of Device: STAPLER
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 5640724
• MDR Text Key: 44795895
• Report Number: MW5062140
• Device Sequence Number: 1
• Product Code: GAG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 33.5
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 36 YR