MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-10 for KARL STORZ 26008BUA-KT SAME manufactured by Karl Storz Endoscopyamerica Inc..
[3472132]
Allegedly, the doctor used the ttts set to conduct an interuterine electrical coagulation of umbilical cord on twin fetuses (selective reduction); there was significant umbilical cord entanglement with one of the fetuses. The doctor's intent was to terminate fetus b and he completed the procedure and considered it successful. On the 6th day post-op, an ultrasound was performed; it showed that twin b remained viable, but twin a had expired. The doctor terminated the wrong fetus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010202439-2013-00022 |
| MDR Report Key | 3193090 |
| Date Received | 2013-06-10 |
| Date of Report | 2013-06-07 |
| Date of Event | 2013-03-28 |
| Date Facility Aware | 2013-05-31 |
| Report Date | 2013-06-07 |
| Date Reported to FDA | 2013-06-07 |
| Date Reported to Mfgr | 2013-06-07 |
| Date Added to Maude | 2013-06-27 |
| 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 |
| Manufacturer Street | 2151 E. GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 902450000 |
| Manufacturer Country | US |
| Manufacturer Postal | 902450000 |
| Manufacturer G1 | KARL STORZ ENDOSCOPYAMERICA INC. |
| Manufacturer Street | 2151 E. GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 90245000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 90245 0000 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARL STORZ |
| Generic Name | RIGID TTTS FETOSCOPY INSTRUMENTS |
| Product Code | HGK |
| Date Received | 2013-06-10 |
| Model Number | 26008BUA-KT |
| Catalog Number | SAME |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 6 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOSCOPYAMERICA INC. |
| Manufacturer Address | TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-06-10 |