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

Catalog Number 0210114000

Device Problem Biocompatibility (2886)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2018

Event Type  malfunction  

Manufacturer Narrative

Product is not available.

Event Description

The user facility reported that the tubing has a yellowish tint to it during a procedure.There was no patient impact, no delay, no medical intervention, and no adverse consequences.

• Brand Name: INTERPULSE HANDPIECE WITH HIGH FLOW TIP
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• Manufacturer Contact: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7955741
• MDR Text Key: 123376851
• Report Number: 0001811755-2018-01739
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 34546540673566
• UDI-Public: 34546540673566
• 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
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• 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: 18097012
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2018
• 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