MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNIVERSAL HANDSWITCH; UNIT, OPERATIVE DENTAL

Catalog Number 5100009000

Device Problem Component Missing (2306)

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

Event Date 09/28/2014

Event Type  malfunction  

Event Description

It was reported that during equipment testing conducted by a manufacturer field service technician that the handswitch was missing the metal band.No patient involvement, no clinically significant delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

Evaluation, conclusion: the device has been scrapped by the manufacturer.

• Brand Name: UNIVERSAL HANDSWITCH
• Type of Device: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 4199052
• MDR Text Key: 14876143
• Report Number: 0001811755-2014-03767
• Device Sequence Number: 1
• Product Code: EIA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2014

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 Catalogue Number: 5100009000
• Device Lot Number: 12282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2014
• Initial Date Manufacturer Received: 09/28/2014
• Initial Date FDA Received: 10/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1