MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-04-22 for BURR, 4MM, 70DEG, DIAMOND TAPER, 5/PK BUR4070DT manufactured by Gyrus Acmi Inc.
[21081147]
Olympus was informed that during a procedure, the tip of the device broke off inside the pt and was lodged in the pt for a moment. No patient injury was reported. No additional information was provided. Olympus followed up with the user facility via telephone and in writing to obtain more detailed information about the reported event, but with no results.
Patient Sequence No: 1, Text Type: D, B5
[21220053]
The device referenced in this report was returned to olympus for evaluation. The reported phenomenon was confirmed. A visual inspection of the device under a microscope found that the locking notches of the burr that the blade is attached to broke off. The broken piece was not returned. The dimension of the broken burr measured approximately 14mm from the distal tip. When tested with an olympus test equipment, the nose cone of the device rotated smoothly and the inner blade attached to the shaft without any resistance. However, the functionality test could not be performed due to the fact that the burr was broken. The most likely cause of the reported phenomenon is excessive force being applied on the burr of the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2015-00206 |
| MDR Report Key | 4726931 |
| Report Source | 05,06 |
| Date Received | 2015-04-22 |
| Date of Report | 2015-03-25 |
| Date of Event | 2015-03-25 |
| Date Mfgr Received | 2015-03-25 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2015-06-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI SCHAMBACH |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BURR, 4MM, 70DEG, DIAMOND TAPER, 5/PK |
| Generic Name | BURR, 4MM, 70DEG, DIAMOND TAPER, 5/PK |
| Product Code | HBG |
| Date Received | 2015-04-22 |
| Returned To Mfg | 2015-04-06 |
| Model Number | BUR4070DT |
| Catalog Number | BUR4070DT |
| Lot Number | IH796865 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI INC |
| Manufacturer Address | 136 TURNPIKE RD SOUTHBOROUGH MA 01772210 US 01772 2104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-22 |