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

Catalog Number 0210112000

Device Problem Biocompatibility (2886)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2018

Event Type  malfunction  

Event Description

It was reported that during the procedure black liquid started flowing out of the tip.The procedure was completed successfully with no clinically significant medical delay and no adverse consequences to the patient.

Event Description

It was reported that during the procedure black liquid started flowing out of the tip.The procedure was completed successfully with no clinically significant medical delay and no adverse consequences to the patient.

• Brand Name: INTERPULSE HANDPIECE WITH SOFT TISSUE 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 00615
• Manufacturer Contact: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7478030
• MDR Text Key: 107080202
• Report Number: 0001811755-2018-00948
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 4546540144232
• UDI-Public: (01)4546540144232
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0210112000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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