MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-04-11 for CONTROL UNIT, INTELIJET, 120V 4350H manufactured by Smith & Nephew, Inc.- Endoscopy Div.
[171567]
Unit pressure was set at 70 mmhg and was not keeping pressure in the joint. The unit then began to pump at an extremely high rate. This process continued throughout the surgery. There were no injuries or complications to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1643264-2000-00012 |
| MDR Report Key | 274143 |
| Report Source | 05,06 |
| Date Received | 2000-04-11 |
| Date of Event | 2000-03-13 |
| Date Mfgr Received | 2000-03-20 |
| Date Added to Maude | 2000-04-21 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | STEVE JACKSON |
| Manufacturer Street | 3600 NW 138TH |
| Manufacturer City | OKLAHOMA CITY OK 73134 |
| Manufacturer Country | US |
| Manufacturer Postal | 73134 |
| Manufacturer Phone | 4059363000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTROL UNIT, INTELIJET, 120V |
| Generic Name | ARTHROSCOPIC IRRIGATION PUMP |
| Product Code | HRT |
| Date Received | 2000-04-11 |
| Returned To Mfg | 2000-03-20 |
| Model Number | 4350H |
| Catalog Number | 4350H |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 265354 |
| Manufacturer | SMITH & NEPHEW, INC.- ENDOSCOPY DIV |
| Manufacturer Address | 160 DASCOMB ROAD ANDOVER MA 01810 US |
| Baseline Brand Name | SERVICE REP, C/U, INTELIJET, 120V |
| Baseline Generic Name | ARTHROSCOPIC IRRIGATION PUMP |
| Baseline Model No | 4350H |
| Baseline Catalog No | 4350H |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-04-11 |