MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-17 for VERSAJET EXACT ASSY, 15 DEGREE X 14MM 66800040 manufactured by Smith & Nephew Medical Ltd..
[181662437]
It was reported that at the beginning of the procedure 2 handpieces did not start correctly and did not work at all. All routine checks have been completed. The o. R. Assistant noticed when disconnecting the handpieces from the pump interface that saline was flowing from the pump interface. As a result of this situation, the surgeon decided to proceed with manual debridement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043484-2020-00108 |
| MDR Report Key | 9718633 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-17 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-02-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR SARAH FREESTONE |
| Manufacturer Street | 101 HESSLE ROAD |
| Manufacturer City | HULL HU3 2BN |
| Manufacturer Country | UK |
| Manufacturer Postal | HU3 2BN |
| Manufacturer Phone | 0447940038 |
| Manufacturer G1 | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Street | 101 HESSLE ROAD |
| Manufacturer City | HULL HU3 2BN |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HU3 2BN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERSAJET EXACT ASSY, 15 DEGREE X 14MM |
| Generic Name | LAVAGE, JET |
| Product Code | FQH |
| Date Received | 2020-02-17 |
| Catalog Number | 66800040 |
| Lot Number | 50728625 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Address | 101 HESSLE ROAD HULL UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-17 |