MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE IRRIGATION ONLY HANDPIECE WITH SOFT TISSUE TIP; LAVAGE, JET

Catalog Number 0210212000

Device Problem Biocompatibility (2886)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2017

Event Type  malfunction  

Event Description

The user facility reported, there was a brown stain on the tub when the box was opened for preparation of a procedure.No patient impact, no medical intervention, no delay and no adverse consequences.

Manufacturer Narrative

Correction: customer discarded the device.

Event Description

The user facility reported, there was a brown stain on the tub when the box was opened for preparation of a procedure.No patient impact, no medical intervention, no delay and no adverse consequences.

• Brand Name: INTERPULSE IRRIGATION ONLY HANDPIECE WITH SOFT TISSUE 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: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6941185
• MDR Text Key: 89952011
• Report Number: 0001811755-2017-01931
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 4546540144287
• UDI-Public: (01)4546540144287
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0210212000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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