MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-04 for KARL STORZ RIGID TTTS FETOSCOPY INSTRUMENT SET 26008AA manufactured by Karl Storz Endoscopy America, Inc.
[18528105]
Physician was to perform an intrauterine electrocoagulation of umbilical cord of twin b. There was significant cord entanglement. The procedure was completed and believed to have been successful. On the sixth day post-op an ultrasound was performed and it was determined that twin b remained viable, however, there was a demise of twin a.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030461 |
| MDR Report Key | 3161525 |
| Date Received | 2013-06-04 |
| Date of Report | 2013-06-04 |
| Date of Event | 2013-03-28 |
| Date Added to Maude | 2013-06-11 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARL STORZ RIGID TTTS FETOSCOPY INSTRUMENT SET |
| Generic Name | RIGID TTTS FETOSCOPE |
| Product Code | HGK |
| Date Received | 2013-06-04 |
| Model Number | 26008AA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOSCOPY AMERICA, INC |
| Manufacturer Address | EL SEGUNDO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2013-06-04 |