MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-02-18 for ZUMI - 4.5 * manufactured by Zsi Gynecology Products.
[103354]
Zumi balloon tested pre-operatively and found to be intact. During surgical procedure, and the process of elevating the uterus, the zumi uterine manipulator went through the fundus of the uterus. Upon removal of the zumi, the balloon appeared to be deflated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 173942 |
| MDR Report Key | 173942 |
| Date Received | 1998-02-18 |
| Date of Report | 1998-02-18 |
| Date of Event | 1998-02-16 |
| Date Facility Aware | 1998-02-16 |
| Report Date | 1998-02-18 |
| Date Reported to Mfgr | 1998-02-18 |
| Date Added to Maude | 1998-06-26 |
| 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 | 0 |
| 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 | ZUMI - 4.5 |
| Generic Name | UTERINE MANIPULATOR INJECTOR - 4.5MM |
| Product Code | HDC |
| Date Received | 1998-02-18 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 059052 |
| ID Number | REF:1151 |
| Device Expiration Date | 2002-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 169118 |
| Manufacturer | ZSI GYNECOLOGY PRODUCTS |
| Manufacturer Address | 21540-B PRARIE ST CHATSWORTH CA 91311 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-02-18 |