MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-31 for SPY-PHI DRUG DRAPE KIT HH9006 manufactured by Novadaq Technologies.
[115783878]
Novadaq technologies, inc. Was acquired by stryker. This mdr is being submitted late because it was identified during the integration and remediation activities initiated by stryker endoscopy in conjunction with this acquisition. The spy-phi drape is a sterile, single use drape intended to be placed over the spy-phi device and provide a sterile barrier of the imaging head so that the spy-phi device can be used in the sterile operating environment. The spy-phi device itself is intended to be used at a working distance of? 10 to 40 cm (4 to 15 inches) from the surface or tissue to be imaged? In accordance with pg. 58 of the spy-phi operator? S manual. The breach in the drape material was observed after the device was inserted into the breast pocket of a patient by the operating surgeon. To date, novadaq has not received any reports of patient injury or infection as a result of hh2000 drape sterile barrier failure. This event was initially reported under the associated recall z-3236-2017.
Patient Sequence No: 1, Text Type: N, H10
[115783879]
It was reported that pinhole leaks were found in the drape. No adverse consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012345110-2018-00006 |
| MDR Report Key | 7737479 |
| Date Received | 2018-07-31 |
| Date of Report | 2018-07-31 |
| Date of Event | 2017-06-14 |
| Date Mfgr Received | 2017-06-14 |
| Date Added to Maude | 2018-07-31 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. VICTORIA MILICH |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | NOVADAQ TECHNOLOGIES |
| Manufacturer Street | 8329 EASTLAKE DRIVE, UNIT 101 BURNABY |
| Manufacturer City | BRITISH COLUMBIA V5A 4W2 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | V5A 4W2 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SPY-PHI DRUG DRAPE KIT |
| Generic Name | COVER, BARRIER, PROTECTIVE |
| Product Code | MMP |
| Date Received | 2018-07-31 |
| Catalog Number | HH9006 |
| Lot Number | 1704F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVADAQ TECHNOLOGIES |
| Manufacturer Address | 8329 EASTLAKE DRIVE, UNIT 101 BURNABY BRITISH COLUMBIA V5A 4W2 CA V5A 4W2 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-31 |