MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-11-01 for PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN 00-5150-475-00 manufactured by Zimmer Surgical.
[4076652]
It was reported that the tip from the zimmer pulsavac plus popped off during surgery. Additional clinical follow up with the customer indicated that during an abdominal surgical procedure, the fan spray tip fell off after coming in contact with the tissue. The tip was retrieved after minor manual exploration of the cavity. There was no impact to the procedure, patient or user as a result of the tip falling off. The procedure was completed using the same pulsavac, which was discarded afterwards.
Patient Sequence No: 1, Text Type: D, B5
[11434993]
The device was not returned to the manufacturer for evaluation. A review of the manufacturing records was performed and there were no nonconformances during manufacture that would be related to this complaint. All testing requirements were met. The cause of this complaint cannot be determined because the device was not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526350-2013-00642 |
| MDR Report Key | 3573343 |
| Report Source | 05,07 |
| Date Received | 2013-11-01 |
| Date of Report | 2013-10-03 |
| Date of Event | 2013-10-01 |
| Date Mfgr Received | 2013-10-03 |
| Device Manufacturer Date | 2013-09-01 |
| Date Added to Maude | 2014-02-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHLEEN SMITH |
| Manufacturer Street | 200 WEST OHIO AVE. |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal | 44622 |
| Manufacturer Phone | 3303438801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN |
| Generic Name | PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN |
| Product Code | GQH |
| Date Received | 2013-11-01 |
| Model Number | NA |
| Catalog Number | 00-5150-475-00 |
| Lot Number | 62447466 |
| ID Number | NA |
| Device Expiration Date | 2016-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL |
| Manufacturer Address | 200 WEST OHIO AVE. DOVER OH 44622 US 44622 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-01 |