MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-11 for JARIT COHEN 505-230 manufactured by Integra Lifesciences Corporation.
[17883703]
Patient was discharged home after an outpatient laparoscopic/ gynecological procedure. Patient was trying to void at home when a "large metal object" came out of her vagina. She reported this to her surgeon immediately, who identified the object as the cervical cone portion of a cohen acorn cannula, intrauterine probe, spring-mounted, forceps holder, that was placed into the patient during the procedure. The cervical 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 the surgeon nor the surgical tech noticed it was missing upon removal of the cannula. What was the original intended procedure? Diagnositic laparoscopy and drainage right ovarian cyst. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3174488 |
| MDR Report Key | 3174488 |
| Date Received | 2013-06-11 |
| Date of Report | 2013-06-11 |
| Date of Event | 2013-06-07 |
| Report Date | 2013-06-11 |
| Date Reported to FDA | 2013-06-11 |
| Date Reported to Mfgr | 2013-06-18 |
| Date Added to Maude | 2013-06-18 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JARIT COHEN |
| Generic Name | GYNECOLOGICAL SURGICAL INSTRUMENT |
| Product Code | HCZ |
| Date Received | 2013-06-11 |
| Model Number | 505-230 |
| Catalog Number | 505-230 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 4900 CHARLEMAR DRIVE BLDG A CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-11 |