MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO INTERPULSE HANDPIECE WITH HIGH FLOW TIP; LAVAGE, JET

Catalog Number 0210114000

Device Problem Free or Unrestricted Flow (2945)

Patient Problem No Information (3190)

Event Date 07/16/2014

Event Type  malfunction  

Event Description

It was reported that the interpulse handpiece with high flow tip was allowing patient matter to splatter throughout the operating room during use.Attempts to obtain additional information were made, but were not successful.No patient or user injuries or adverse consequences were reported.

Manufacturer Narrative

The product was not available to the manufacturer for investigation, therefore, the reported event was not able to be confirmed.According to the event as reported by the customer, this is potentially a zimmer product as it was described as a "pulsevac." attempts to obtain additional information and the product for evaluation were made, but were not successful.

Event Description

It was reported that the interpulse handpiece with high flow tip was allowing patient matter to splatter throughout the operating room during use.Attempts to obtain additional information were made, but were not successful.No patient or user injuries or adverse consequences were reported.

Manufacturer Narrative

A follow up report will be filed after the device is received and the quality investigation has been completed.

• Brand Name: INTERPULSE HANDPIECE WITH HIGH FLOW TIP
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 0061 5
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 3964857
• MDR Text Key: 4902913
• Report Number: 0001811755-2014-02695
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2014

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: 0210114000
• Device Lot Number: 14098012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/29/2014
• Initial Date FDA Received: 07/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/08/2014
• 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