MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA ASPEN FLEXIBLE UNBANDED LIGHT HANDLE COVER, NON-STERILE

Model Number LT-F05NS

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

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

Event Date 11/16/2018

Event Type  malfunction  

Manufacturer Narrative

Aspen surgical received a report from the distributor indicating that a flexible light handle cover was falling off of the lights having the potential to contaminate the sterile field.No injury/death was reported.No lot number or sample were provided for review.Cause not established.With no lot number or sample provided, no further information is available on the product at this time.However, if a sample becomes available and any additional relevant information is identified following evaluation, any additional relevant information will be submitted in a supplemental report.Device not returned.

Event Description

Aspen surgical received a report from the distributor indicating that a flexible light handle cover was falling off of the lights.The item was in use.No injury/death was reported.This report was filed in our complaint handling system as number (b)(4).

• Brand Name: ASPEN FLEXIBLE UNBANDED LIGHT HANDLE COVER, NON-STERILE
• Type of Device: LIGHT HANDLE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: jordan hackert ; 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6165367508
• MDR Report Key: 8170527
• MDR Text Key: 131771155
• Report Number: 1836161-2018-00130
• 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: 11/20/2018

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 Model Number: LT-F05NS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/17/2018
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1