MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-07-15 for BOVIE MEDICAL AB05 manufactured by Bovie Medical.
[49668370]
Reported complaint was not confirmed. Customer was removing foreign/metallic part from patient eye, the customer used a bovie ophthalmic burr (1/2mm) lot # 0914b manufacturing date 2014-09-02 expiration date 2018-09 and claimed that immediately the burr was activated on the eye metal shards started to come off of the tip. The device and two additional burrs sealed from same manufacturing and sterile lot were received for evaluation on 4/19/2016. The following process was followed to evaluate the returned devices: device was decontaminated. Devices were visually inspected using magnification and no evidence of a broken part was observed. A comparison between the subjected device and a sample supplied by the customer for the same manufacturing lot number and sterile lot number was performed. Both samples were set side by side and 30 x magnifications was used to observe any difference between them and no evidence of degradation or damages were observed both pieces looks identical. A top view was also observed and both piece shows the star shape, both pieces look identical they are not showing any sign of broken pieces. Both pieces looks intact and per specification. As per specification the dimensions for the tip shall be 0. 026-0. 022 in using caliper the tip was measured and found to be 0. 024 in. Tip was found to be within specification. It was confirmed during the initial conversation with office manager that the doctor was removing foreign metallic parts from the patient eye. It was also confirmed that the dr. Was using a non bovie brand handle. As per investigation this complaint was not confirmed.
Patient Sequence No: 1, Text Type: N, H10
[49668371]
Doctor was removing foreign/metallic parts from patient eye and replaceable burrs was used. Doctor alleged that the shards of the ab05 tip broke off immediately when activated in the eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007593903-2016-00003 |
| MDR Report Key | 5797727 |
| Report Source | USER FACILITY |
| Date Received | 2016-07-15 |
| Date of Report | 2016-05-05 |
| Date of Event | 2016-04-01 |
| Date Mfgr Received | 2016-04-19 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2016-07-15 |
| 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 | MRS JULIE MCDONALD |
| Manufacturer Street | 5115 ULMERTON RD |
| Manufacturer City | CLEARWATER FL 337604004 |
| Manufacturer Country | US |
| Manufacturer Postal | 337604004 |
| Manufacturer Phone | 7278035445 |
| Manufacturer G1 | BOVIE MEDICAL |
| Manufacturer Street | 5115 ULEMERTO RD |
| Manufacturer City | CLEARWATER FL 337604004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 337604004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOVIE MEDICAL |
| Generic Name | BURR 1/2MM 10/BOX |
| Product Code | HOG |
| Date Received | 2016-07-15 |
| Returned To Mfg | 2016-04-19 |
| Catalog Number | AB05 |
| Lot Number | 0914B |
| Device Expiration Date | 2018-09-01 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOVIE MEDICAL |
| Manufacturer Address | 5115 ULMERTON RD CLEARWATER FL 337604004 US 337604004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-07-15 |