MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-07-10 for ROWEN PAHCO SPATULA K3-2398 manufactured by Katena Products, Inc..
[18930336]
Outpatient in for cataract repair. Surgeon used chopper during procedure and when the instrument was removed, an 1. 5mm metal tip was missing from the instrument. Instrument did not come in contact with any hard tissue or surfaces during the procedure. This required extensive direct visualization of the area and an x-ray to rule out the presence of a foreign body within the ocular cavity.
Patient Sequence No: 1, Text Type: D, B5
[19049841]
Upon receipt of med-watch form 3500 (pg #1 only) from user facility, manufacturer then contacted the user facility to inquire of reported event. Verbally confirmed from user facility risk mgmt that "pt has no issues and outcome is good - only prolonged med intervention": also confirmed that the user facility is unwilling to release the subject instrument for evaluation - but, would take magnified photographs of the instrument - manufactured not received to date. Based on this at the time of this report, the subject device is made available to the manufacturer. After a later date, a follow-up med-watch will be filed with evaluation results. A review of the manufacturers complaint handling system database confirms this is only the second reported event of this nature for this device since the device was placed into commercial distribution (b)(4) 1994. Examination of a rep sample found no abnormalities that could cause a product failure during the intended use and normal product handling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242450-2014-00001 |
| MDR Report Key | 3964831 |
| Report Source | 06 |
| Date Received | 2014-07-10 |
| Date of Report | 2014-06-04 |
| Date of Event | 2014-06-04 |
| Date Facility Aware | 2014-06-04 |
| Date Reported to Mfgr | 2014-06-09 |
| Date Mfgr Received | 2014-06-13 |
| Date Added to Maude | 2014-07-30 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | BRYAN WEINMANN |
| Manufacturer Street | 4 STEWART CT. |
| Manufacturer City | DENVILLE NJ 07834 |
| Manufacturer Country | US |
| Manufacturer Postal | 07834 |
| Manufacturer Phone | 9739891600 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROWEN PAHCO SPATULA |
| Generic Name | OPHTHALMIC SPATULA/CHOPPER |
| Product Code | HND |
| Date Received | 2014-07-10 |
| Model Number | K3-2398 |
| Catalog Number | K3-2398 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KATENA PRODUCTS, INC. |
| Manufacturer Address | DENVILLE NJ 07834 US 07834 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-10 |