MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO SURGILAV PLUS HANDPIECE WITH MULTI-ORIFICE TIP AND SOFT CONE SPLASH SHIELD; LAVAGE, JET

Catalog Number 0207559000

Device Problem Biocompatibility (2886)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2017

Event Type  malfunction  

Manufacturer Narrative

Customer discarded product.

Event Description

The user facility reported after opening the package, there was a liquid found on the product during a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: SURGILAV PLUS HANDPIECE WITH MULTI-ORIFICE TIP AND SOFT CONE SPLASH SHIELD
• 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: 6419442
• MDR Text Key: 70422530
• Report Number: 0001811755-2017-00777
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• 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: 03/20/2017

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: 0207559000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2017
• Initial Date FDA Received: 03/20/2017
• 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