MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA ALC PLUS DISPOSABLE LIGHT HANDLE COVER STERILE

Model Number LT-ALC01

Device Problems Hole In Material (1293); Out-Of-Box Failure (2311); Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Patient Involvement (2645)

Event Date 09/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported that entire quantity received had holes.Customer is not sure sterility can be guaranteed.

• Brand Name: ALC PLUS DISPOSABLE LIGHT HANDLE COVER STERILE
• Type of Device: LIGHT HANDLE COVER
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer Contact: bradley liske ; 6945 southbelt dr. s.e.; caledonia, MI 49316
• MDR Report Key: 6063187
• MDR Text Key: 59013408
• Report Number: 1836161-2016-00095
• Device Sequence Number: 1
• Product Code: FTA
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: LT-ALC01
• Device Lot Number: 88626
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2016
• 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