MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07,08 report with the FDA on 2011-02-11 for BUR 8550810 10PK OPHTHALMIC 1MM manufactured by Medtronic Xomed, Inc..
[17470005]
The medwatch was received in the mail from the (b)(4) from the user/facility. This medwatch notification came through (b)(4). (b)(4). The medwatch stated that the patient was seen in urgent care. The doctor was attempting to remove a rust ring with an ophthalmic burr device. The burr device that was used created metal shards that went into the patient's eye, leaving a metallic foreign body after use. The patient was referred to ophthalmology for follow up. The patient was informed regarding the burr issue. The patient did not complain of vision disturbance following procedure. Alcaine drops were used previous to procedure so patient remained topically anesthetized upon discharge to the ophthalmology office following the device malfunction. It appears that the plastic sheaths inside the sealed packages are not intact. The customer returned one burr used in surgery. The customer also returned sterile packs of burr from the reported lot 68379800. Examination of used sample indicated no metal shavings on burr. No defects found with burr- burr head fully intact. Examination of sterile burr indicated no metal shavings. No defects found with burr and no defects found with tip cover. The comparison of the returned used complaint sample vs returned unused sample shows no clear distinction difference in product shape. The weight comparison of the returned used part measured 0. 6103g vs unused new part measured 0. 6090g. These results suggest burr did not fragment during use. No significant amount of the used burr head material was lost during use.
Patient Sequence No: 1, Text Type: D, B5
[17596950]
Any missing or incomplete data on this form 3500a is the result of information not being provided or released by the reporter, despite attempts to obtain the required information. The record of these attempts are documented in the complaint record. This product was being used for treatment, and not diagnosis. A review of the device history record found no abnormal conditions or irregularities that suggest faulty manufacturing. The product is inspected for the quality of workmanship (includes cutting edge). The pvc tubing (used to cover/protect tip during package transport) is placed onto part and is part of the acceptance criteria per the specification. The analysis of the raw material (component level) used on the finished goods meets specification. Overall- the analysis of the returned product vs unused product revealed no clear distinction; thus, we could see no fault with the product. No evidence of loose foreign matter/body was returned with part. The "foreign body" found in surgical area (patient's eye) is unknown. Patient current condition: "the patient is doing fine. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2011-00010 |
| MDR Report Key | 1986202 |
| Report Source | 05,06,07,08 |
| Date Received | 2011-02-11 |
| Date of Report | 2011-01-21 |
| Date of Event | 2010-12-30 |
| Date Mfgr Received | 2011-01-21 |
| Device Manufacturer Date | 2010-06-24 |
| Date Added to Maude | 2011-02-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. MIKE MOSBY MOSBY |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042797584 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUR 8550810 10PK OPHTHALMIC 1MM |
| Generic Name | BURR, CORNEAL, BATTERY-POWERED |
| Product Code | HOG |
| Date Received | 2011-02-11 |
| Returned To Mfg | 2011-02-02 |
| Model Number | 8550810 |
| Catalog Number | 8550810 |
| Lot Number | 68379800 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-02-11 |