MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2005-04-07 for MICROSPAN SYSTEM GMS805 manufactured by Ethicon, Inc..
[402024]
The sheaths are splitting at the "10% angle" when ancillary instruments are introduced. The channel has been opened with the instruments prior to insertion into the pt, but the sheaths still split when the instruments are introduced during the procedure. No additional info is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2005-00209 |
| MDR Report Key | 591127 |
| Report Source | 01,07 |
| Date Received | 2005-04-07 |
| Date of Report | 2005-03-08 |
| Report Date | 2005-03-08 |
| Date Mfgr Received | 2005-03-08 |
| Date Added to Maude | 2005-04-15 |
| 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 MARK YALE |
| Manufacturer Street | ROUTE 22 WEST PO BOX 151 |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182326 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 310 BROAD ST |
| Manufacturer City | UTICA NY 13501 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 13501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROSPAN SYSTEM |
| Generic Name | SHEATH |
| Product Code | NIH |
| Date Received | 2005-04-07 |
| Returned To Mfg | 2005-03-14 |
| Model Number | NA |
| Catalog Number | GMS805 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 580984 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | ROUTE 22 WEST PO BOX 151 SOMERVILLE NJ 088760151 US |
| Baseline Brand Name | MICROSPAN SYSTEM |
| Baseline Generic Name | SHEATH |
| Baseline Model No | NA |
| Baseline Catalog No | GMS805 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-04-07 |