MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-02-07 for KARL STORZ 11630AA FETOSCOPE manufactured by Karl Storz Gmbh & Co. Kg.
[17372897]
A pregnant mother with identical twins was diagnosed with ttts (twin-to-twin transfusion syndrome). Selective laser photocoagulation using karl storz hde fetoscopy instruments was performed in 2006. Three days later during ultrasound, interuterine death of the donor fetus was discovered. Post procedure, the mother and recipient fetus are reported as doing well. According to the p. I. (principal investigator) who performed this procedure, this event was not related to the use of the fetoscope and a certain percentage of deaths, including intrauterine fetal death, is anticipated for ttts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020550-2007-00002 |
| MDR Report Key | 814431 |
| Date Received | 2007-02-07 |
| Date of Report | 2007-02-06 |
| Date of Event | 2006-12-12 |
| Date Facility Aware | 2007-02-01 |
| Report Date | 2007-02-06 |
| Date Reported to FDA | 2007-02-06 |
| Date Reported to Mfgr | 2007-02-06 |
| Date Added to Maude | 2007-02-13 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARL STORZ |
| Generic Name | FETOSCOPY INSTRUMENT |
| Product Code | HFA |
| Date Received | 2007-02-07 |
| Model Number | 11630AA FETOSCOPE |
| Catalog Number | 11630AA FETOSCOPE |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 801922 |
| Manufacturer | KARL STORZ GMBH & CO. KG |
| Manufacturer Address | * TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2007-02-07 |