MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-06-18 for KARL STORZ manufactured by Karl Storz Gmbh & Co. Kg.
[3628469]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10952188]
Complaint was verified. Light source bulb turns off randomly after several mins of operation. Abrupt light source malfunction has been investigated by the manufacturers and software revision (b)(4) was issued as a result.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2013-00025 |
| MDR Report Key | 3198811 |
| Report Source | 05,06 |
| Date Received | 2013-06-18 |
| Device Manufacturer Date | 2012-06-01 |
| Date Added to Maude | 2013-07-03 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | MITTLESTRASSE 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 | TELE PACK X |
| Product Code | FBP |
| Date Received | 2013-06-18 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2013-06-18 |