MAUDE Adverse Event Report: ZIMMER SURGICAL PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN

Catalog Number 00-5150-475-00

Device Problem Detachment Of Device Component (1104)

Patient Problem Chemical Exposure (2570)

Event Date 11/04/2013

Event Type  malfunction  

Event Description

It was reported that the spray clip came off of the pulsavac plus and sprayed everyone.Add'l clinical f/u with the customer indicated that the tip detaching from the device did not have any harm or impact to the pt or procedure.The location of tip detachment could not be recalled by the customer and it was confirmed that there was no medical intervention or surgical delay involved in the procedure.The customer stated that the surgical team was all equipped with personal protective equipment (face suits); however, the anesthesiologist was without ppe and had direct skin contact with the irrigation fluid spray.It was confirmed that there was no employee seeking a health f/u.

Manufacturer Narrative

Although the device was not returned to the mfr, the cause of the complaint was contributed to the press fit tip locking mechanism on the pulsavac plus.A design change has been implemented to address this issue.

• Brand Name: PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN
• Type of Device: PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM
• Manufacturer (Section D): ZIMMER SURGICAL; 200 west ohio ave.; dover OH 44622
• Manufacturer Contact: kathleen smith ; 200 west ohio ave.; dover, OH 44622 ; 3303438801
• MDR Report Key: 3894259
• MDR Text Key: 4426972
• Report Number: 1526350-2014-00041
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Catalogue Number: 00-5150-475-00
• Device Lot Number: 62468369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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