MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON UNKNOWN - MAXON; MAXON SUTURE

Model Number UNKNOWN - MAXON

Device Problems Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)

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

Event Date 03/06/2015

Event Type  Injury  

Event Description

Procedure: urological.According to the reporter:surgeon using suture maxon cv on a cv-22 needle.Dr attempted to reset the needle in the needle holder and the needle had pulled apart from the suture.Needle was unable to be found.This caused a off count of the suture and potential damage to the patient.Unable to do x-ray due to size of needle.Current patient status is unknown.The issue did not result in any tissue damage or patient injury.Applied another suture.No further information is available from the account.

Manufacturer Narrative

(b)(4).

• Brand Name: UNKNOWN - MAXON
• Type of Device: MAXON SUTURE
• 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: 4724037
• MDR Text Key: 16854893
• Report Number: 1219930-2015-00346
• Device Sequence Number: 1
• Product Code: GAN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN - MAXON
• Device Catalogue Number: UNKNOWN - MAXON
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/10/2015
• Initial Date FDA Received: 04/23/2015
• 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