MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA AMERISURG, SINGLE TIP KITTNER - STERILE

Model Number 13300-AS

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Patient Involvement (2645)

Event Date 09/20/2017

Event Type  malfunction  

Manufacturer Narrative

Multiple attempts were made to obtain photos or samples.Investigation will be reopened if either become available.Device requested but not provided.

Event Description

The screw on side of the kittner completely fell off.The device was not in use at time of alleged event.

• Brand Name: AMERISURG, SINGLE TIP KITTNER - STERILE
• Type of Device: KITTNER
• 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: 6956234
• MDR Text Key: 90647003
• Report Number: 1836161-2017-00113
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K913500
• 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: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 13300-AS
• Device Lot Number: 124291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2017
• 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: Unknown
• Patient Sequence Number: 1