MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA MEDICAL ACTION LIGHT SHIELD, SEMI-RIGID, NON-STERILE

Model Number NB8001

Device Problem Crack (1135)

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

Event Date 09/18/2017

Event Type  malfunction  

Event Description

Multiple instances of cracked light shields item nb8001 lot 141757.The cracks are in the handle.

• Brand Name: MEDICAL ACTION LIGHT SHIELD, SEMI-RIGID, NON-STERILE
• Type of Device: LIGHT SHIELD
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: megan morrissey ; 6945 southbelt dr. s.e.; caledonia, MI 49316
• MDR Report Key: 6957357
• MDR Text Key: 90647070
• Report Number: 1836161-2017-00111
• Device Sequence Number: 1
• Product Code: FTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: NB8001
• Device Lot Number: 141757
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1