MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-23 for GYN FORCEPS GYA 5 manufactured by Olympus.
[4094185]
On (b)(6) 2014: female pt who underwent outpatient laparoscopic tubal ligation, dilation and curettage and hysteroscopy, novasure and removal of paragard intrauterine device (iud). After multiple repeated/unsuccessful attempts to remove the iud, surgeon decided to use an operative scope and grasper to obtain iud. In the process of "grabbing it" with the grasper, a portion of the tip (approx 0. 5 cm x 2. 7. ) of the grasper broke and was within the pt. Xray was obtained and confirmed that the tip/metal piece remained in pt's uterus. Utilizing a hysteroscopy the metal tip was found and removed from pt. Surgery was completed and pt sent to recovery on (b)(6) 2013 - post recovery pt was discharged home in stable condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034043 |
| MDR Report Key | 3599468 |
| Date Received | 2014-01-23 |
| Date of Report | 2014-01-20 |
| Date of Event | 2014-01-15 |
| Date Added to Maude | 2014-01-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GYN FORCEPS |
| Generic Name | SEMI-RIGID ALLIGATOR GRASPER |
| Product Code | HCZ |
| Date Received | 2014-01-23 |
| Model Number | GYA 5 |
| ID Number | 5 FR. 42 CM |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-01-23 |