MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA RIGID ADAPTOR - BERCHTOLD E-SERIES/MONITOR; LIGHT HANDLE ADAPTOR

Model Number LT-9731X

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Misassembly by Users (3133)

Patient Problem No Information (3190)

Event Date 02/22/2017

Event Type  malfunction  

Event Description

Details of complaint ," entire adaptor fell into field during procedure." product was used as intended but not installed with correct screw.

• Brand Name: RIGID ADAPTOR - BERCHTOLD E-SERIES/MONITOR
• Type of Device: LIGHT HANDLE ADAPTOR
• 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: 6418280
• MDR Text Key: 70642993
• Report Number: 1836161-2017-00023
• 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: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: LT-9731X
• Device Lot Number: 113544
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1