MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-01 for CANNULA, COHEN, W/TWO ACORNS 8378.00 manufactured by Richard Wolf Medical Instruments Corp..
[53791549]
A full investigation could not be completed as the actual device was not returned to the richard wolf facility as of 04/30/2013. Device is screwed on to end of intrauterine probe. Ifu instruct user "immediately before and after each use, check the products for damage, loose parts and completeness. " most likely cause of acorn coming loose is user error/handling. Labeling was reviewed and found to be adequate. Ie intended use, indications and field of use, preparation and cautions. Trending showed there has been one similar incident in the last four years. (mdr1418479-2011-0020). Lot number supplied by customer was not found in our system and calls to initial reporter have not been returned. The last purchase of this device type, from this customer, was in 2008 (lot 183j08). Rwmic considers this matter closed. However, in the event we receive the device or additional information isa received, we will provide fda with follow-up information.
Patient Sequence No: 1, Text Type: N, H10
[53791550]
Sterile processing department reported acorn tip missing two hours post procedure. Doctor notified of missing device and search of equipment, linens and room conducted with no results. Doctor notified patient and suggested patient perform self examination, nothing abnormal found. Patient presented to doctors office one day post-op with pain. Acorn was found in vagina.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2013-00013 |
| MDR Report Key | 3112006 |
| Date Received | 2013-05-01 |
| Date of Report | 2013-04-01 |
| Date of Event | 2012-11-28 |
| Date Added to Maude | 2013-05-14 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAWN CLARK |
| Manufacturer Street | 353 CORPORATE WOODS PKWY. |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8479558016 |
| Manufacturer G1 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Manufacturer Street | 353 CORPORATE WOODS PKWY. |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60061 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CANNULA, COHEN, W/TWO ACORNS |
| Generic Name | CANNULA, COHEN, W/TWO ACORNS |
| Product Code | HHI |
| Date Received | 2013-05-01 |
| Model Number | 8378.00 |
| Catalog Number | 8378.00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Manufacturer Address | VERNON HILLS IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-05-01 |