MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-09-03 for DISPOSABLE FLEXIBLE CURETTE 9MM 022009 manufactured by Medgyn.
[20224585]
Flexible curette broke off during a d and c procedure while in the uterus and could not be located and removed. Pt underwent diagnostic hysteroscopy, ultrasound, x-ray, and open laparoscopy w/hasson cannula for visualization in an attempt to locate the piece and check for perforation. No perforation was found and the broken piece could not be found. The pt was admitted.
Patient Sequence No: 1, Text Type: D, B5
[20596910]
See complaint investigation report attached. We did not receive the product back from the user for eval, received only report. An eval was performed using two different lots of flexible curettes. Evaluated the mfr process - visual testing - no unusual problems, no cracks on cannula. Checked quality records - no indication of tip breakage or any other quality problems. Physical testing - no cracks or breakage after striking on a hard surface or bending back and forth 20 times. Evaluated other complaints - (b)(4) physical testing to interaction with other devices revealed that the cannula could be pierced but not broken except with excessive force. Breakage as alleged could not be duplicated. The cause of the event is unk and cannot be determined. Final conclusion: as the complaints are so spread out and few in number and the testing for each complaint is inconclusive, no probable cause can be assigned. The issue will continue to be monitored as more info is obtained. No corrective action will be issued. A medwatch report will be filed with the fda prior to (b)(4) 2009 (30 days from receipt).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1450908-2009-00002 |
| MDR Report Key | 2625764 |
| Report Source | 05,06 |
| Date Received | 2009-09-03 |
| Date of Report | 2009-08-20 |
| Date of Event | 2009-08-12 |
| Date Facility Aware | 2009-08-13 |
| Report Date | 2009-08-13 |
| Date Reported to Mfgr | 2009-08-17 |
| Date Mfgr Received | 2009-08-24 |
| Device Manufacturer Date | 2004-12-08 |
| Date Added to Maude | 2012-06-25 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | RAMESH VYAS |
| Manufacturer Street | 328 NORTH EISENHOWER LN. |
| Manufacturer City | LOMBARD IL 60148 |
| Manufacturer Country | US |
| Manufacturer Postal | 60148 |
| Manufacturer Phone | 6306274105 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE FLEXIBLE CURETTE 9MM |
| Generic Name | FLEXIBLE CURETTE |
| Product Code | HCY |
| Date Received | 2009-09-03 |
| Catalog Number | 022009 |
| Lot Number | 120845 |
| Device Expiration Date | 2009-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDGYN |
| Manufacturer Address | LOMBARD IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-09-03 |