MAUDE Adverse Event Report: NORTHERN DIGITAL, INC. NDI PASSIVE SPHERES; REFLECTIVE PASSIVE MARKER SPHERE - HAW, OLO

Lot Number 4797801

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 01/21/2011

Event Type  malfunction  

Event Description

Operating room staff at (b)(6) noted a passive marker sphere had delaminated reflective film.This was noted during a procedure.As sphere was used during a procedure it was destroyed via autoclave as it was used in a procedure and considered a biohazard.During investigation it was determined that the adhesive for the film was improperly applied.This issue was corrected and this failure has not recurred since this report.No serious implications to this issue were mentioned by the complainant.No pt was harmed and no serious injury occurred.

• Brand Name: NDI PASSIVE SPHERES
• Type of Device: REFLECTIVE PASSIVE MARKER SPHERE - HAW, OLO
• Manufacturer (Section D): NORTHERN DIGITAL, INC.; waterloo, ontario ; CA
• Manufacturer Contact: gregory gotthelf ; brecha e99 l15e; parque industrial reynosa; reynosa tamp CP887-80 ; MX CP88780 ; 7166916333
• MDR Report Key: 4170682
• MDR Text Key: 19086357
• Report Number: 3002743211-2014-00001
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K033621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 4797801
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2011
• Initial Date FDA Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1