MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-07-02 for COHEN INTRAUTERINE PROBE 505230 manufactured by Integra York, Pa Inc..
[19416774]
Medwatch #(b)(4) was received on (b)(6) 2013 stating that; patient was discharged home after an outpatient laparoscopic/gynecological procedure. Patient was trying to void when a "large metal object" came out of her vagina. She reported this to her surgeon who identified the object as the cervical cone portion of a cohen acorn cannula. The cone was inadvertently left inside the vagina upon removal of the cannula. The cervical cone portion of the device screws onto the distal end of the cannula and was assumed to be loose upon removal. Neither surgeon nor the surgical tech noticed it was missing upon removal. On (b)(6) 2013 customer reports the device was expelled the same day as surgery, no harm done to the patient.
Patient Sequence No: 1, Text Type: D, B5
[19471469]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2013-00044 |
| MDR Report Key | 3212341 |
| Report Source | 06 |
| Date Received | 2013-07-02 |
| Date of Report | 2013-07-02 |
| Date of Event | 2013-06-07 |
| Date Mfgr Received | 2013-06-24 |
| Date Added to Maude | 2013-07-11 |
| 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 | 0 |
| Manufacturer Contact | SANDRA LEE |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COHEN INTRAUTERINE PROBE |
| Generic Name | NA |
| Product Code | HCZ |
| Date Received | 2013-07-02 |
| Catalog Number | 505230 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-02 |