MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-12-31 for KARL STORZ 12060C manufactured by Karl Storz Gmbh & Co. Kg.
[1275188]
Allegedly, during an esophagoscopy the pt's esophagus was perforated; the perforation was repaired and pt was released after one week in hospital after doctor confirmed area healed. Later, the pt returned to the hospital and it was found that the repair had broken. Doctor repaired again.
Patient Sequence No: 1, Text Type: D, B5
[8424587]
The 12060c was examined and found to be in good working condition and within specifications. There was no damage noted on product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2009-00040 |
| MDR Report Key | 1582691 |
| Report Source | 06 |
| Date Received | 2009-12-31 |
| Date of Report | 2009-12-29 |
| Date of Event | 2009-08-06 |
| Date Facility Aware | 2009-12-02 |
| Report Date | 2009-12-29 |
| Date Reported to FDA | 2009-12-29 |
| Date Reported to Mfgr | 2009-12-29 |
| Device Manufacturer Date | 2009-04-01 |
| Date Added to Maude | 2011-03-30 |
| 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 | ESOPHAGOSCOPE |
| Product Code | EOX |
| Date Received | 2009-12-31 |
| Model Number | 12060C |
| Catalog Number | 12060C |
| Lot Number | DB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | Y |
| 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. Other | 2009-12-31 |