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

Catalog Number 0210114100

Device Problem Disassembly (1168)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 02/11/2015

Event Type  Injury  

Event Description

It was reported that during a surgical procedure at the user facility, the tip of the handpiece disassembled and the nozzle fell into the surgical site.The procedure was completed successfully with the same device without a clinically significant delay.The tip was recovered and removed.An x-ray was taken to confirm no other device components were left in the surgical site.No adverse consequences were reported.

Event Description

It was reported that during a surgical procedure at the user facility, the tip of the handpiece disassembled and the nozzle fell into the surgical site.The procedure was completed successfully with the same device without a clinically significant delay.The tip was recovered and removed.An x-ray was taken to confirm no other device components were left in the surgical site.No adverse consequences were reported.

Manufacturer Narrative

Evaluation in progress.

Manufacturer Narrative

A total 2 tips were received for evaluation inside a plastic bag.Upon visual inspection, it was observed that the suction and irrigation tubes were broken.Therefore, the claimed condition was not confirmed.

• Brand Name: INTERPULSE HANDPIECE WITH COAXIAL 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: 4587053
• MDR Text Key: 5448976
• Report Number: 0001811755-2015-00853
• 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: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0210114100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 03/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention