MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-02-27 for KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA 59001 manufactured by Welch Allyn.
[3255862]
During a procedure to remove an iud, the health care provider inserted the medium sized speculum, spread the blades open and locked them in place. Seconds after locking the speculum, the first inch and a half of the top blade cracked and broke off inside the patient's vagina. The patient felt a sharp jab and pinch. The provider successfully removed the broken speculum from the patient. Due to the type of procedure the provider was unable to tell if the patient's tissue was affected. The customer did not provide a patient identifier.
Patient Sequence No: 1, Text Type: D, B5
[10649997]
This device has not been returned to welch allyn for evaluation. We are submitting this report in an abundance of caution. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316463-2013-00001 |
| MDR Report Key | 3023079 |
| Report Source | 06 |
| Date Received | 2013-02-27 |
| Date of Report | 2013-01-30 |
| Date of Event | 2013-01-30 |
| Date Mfgr Received | 2013-01-30 |
| Date Added to Maude | 2013-05-07 |
| 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 | PEARLY BHAMBRI, DIRECTOR |
| Manufacturer Street | 4341 STATE ST. RD. P.O. BOX 220 |
| Manufacturer City | SKANEATELES FALLS NY 131530220 |
| Manufacturer Country | US |
| Manufacturer Postal | 131530220 |
| Manufacturer Phone | 3156852568 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KLEENSPEC 590 SERIES DISP. VAGINAL SPECULA |
| Product Code | HIB |
| Date Received | 2013-02-27 |
| Model Number | 59001 |
| Catalog Number | 59001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN |
| Manufacturer Address | 4341 STATE ST. RD. SKANEATELES FALLS NY 13153 US 13153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-27 |