MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON EGIA 60 ARTICULATING VAS/MED SULU; DISPOSABLE STAPLING DEVICE

Model Number EGIA60AVM

Device Problems Crack (1135); Failure to Form Staple (2579); Noise, Audible (3273)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/29/2015

Event Type  Injury  

Event Description

Procedure: hepatic ablation (nephrectomy).According to the reporter: the surgeon fired the stapler, heard crack and had no movement in i beam/blade.The surgeon continued to fire, but felt the stapler sounded odd.Staples formed properly on the patient side but did not form on kidney side.The surgeon had to open the patient to finish the case.The surgeon packed the patient with towels and sutured to stop the bleeding.As such, there was unanticipated extension of incision by more than one inch and there was patient injury or hazard.There was unanticipated blood loss of more than 500cc.Surgery time was extended by more than 30 minutes.There was no unanticipated tissue loss.No device fragments fell into the patient.No reinforcement material was used.The current patient status is that he is fine.

Manufacturer Narrative

(b)(4).

• Brand Name: EGIA 60 ARTICULATING VAS/MED SULU
• Type of Device: DISPOSABLE STAPLING DEVICE
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4931040
• MDR Text Key: 6049340
• Report Number: 1219930-2015-00632
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EGIA60AVM
• Device Catalogue Number: EGIA60AVM
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/01/2015
• Initial Date FDA Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR