MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-10-29 for KARL STORZ 26008AA manufactured by Karl Storz Gmbh & Co. Kg.
[2339320]
The data and info contained herein is being submitted to the fda to comply with the regulations (21 cfr part 803) pertaining to medical device reporting. This mdr is based on preliminary info received by karl storz, who has not conclusively determined the cause of the adverse event. This mdr is, therefore, not intended to and shall not constitute an admission that a reportable event occurred or that any karl storz products were causally related to the incident. A pt pregnant with identical twins was diagnosed with ttts (twins-to-twin transfusion syndrome). Selective laser photocoagulation using karl storz hde fetoscopy instruments was performed on (b)(6) 2011. The following morning ((b)(6) 2011) during f/u cardiac echo to check cardiac function, it was discovered that the recipient fetus had expired. Customer reported that prior to the procedure, the recipient fetus had decreased cardiac function and that the death was not related to the fetoscopy equipment. Post procedure, the mother and donor fetus are reported as doing well.
Patient Sequence No: 1, Text Type: D, B5
[9477877]
According to the nurse coordinator who reported the incident, the event was not related to the use of the fetoscopy equipment. The equipment will not be returned for eval. A certain percentage of deaths, including intrauterine fetal death, is anticipated for ttts.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2011-00044 |
| MDR Report Key | 2319897 |
| Report Source | 05,06 |
| Date Received | 2011-10-29 |
| Date of Report | 2011-10-27 |
| Date of Event | 2011-10-06 |
| Date Facility Aware | 2011-10-21 |
| Report Date | 2011-10-27 |
| Date Reported to FDA | 2011-10-27 |
| Date Reported to Mfgr | 2011-10-27 |
| Date Added to Maude | 2011-11-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | MITTELSTRASSE 8 POSTFACH 230 |
| Manufacturer City | TUTTLINGEN 78503 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78503 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARL STORZ |
| Generic Name | FETOSCOPE |
| Product Code | HGK |
| Date Received | 2011-10-29 |
| Model Number | 26008AA |
| Catalog Number | 26008AA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH & CO. KG |
| Manufacturer Address | TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2011-10-29 |