MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-06-09 for KARL STORZ 26003BA manufactured by Karl Storz Gmbh & Co. Kg.
[1339347]
Allegedly, during a colorectal procedure, doctor laid scope attached to light cable on pt; active light source was not put on standby and the tip of scope made a small burn to the drape. Doctor immediately notice and removed scope; there was no pt impact. Procedure was completed.
Patient Sequence No: 1, Text Type: D, B5
[8555877]
Found the scope to have signs of customer usage/damage. Scope failed leak test. Also found abrasions and nicks on block, shaft and tiny tool marks on taper and post side. The scope, light cable and light source were all tested together and found to function within specifications. None of these findings are relevant to the event reported; the reason drape burned was because user laid scope with active light source on drape without selecting standby function. No pt impact.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2010-00012 |
| MDR Report Key | 1736517 |
| Report Source | 06 |
| Date Received | 2010-06-09 |
| Date of Report | 2010-05-27 |
| Date of Event | 2010-04-30 |
| Date Facility Aware | 2010-04-29 |
| Report Date | 2010-05-27 |
| Date Reported to FDA | 2010-05-27 |
| Date Reported to Mfgr | 2010-05-27 |
| Device Manufacturer Date | 2009-12-01 |
| Date Added to Maude | 2011-04-13 |
| 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 |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARL STORZ |
| Generic Name | RIGID SCOPE |
| Product Code | FBP |
| Date Received | 2010-06-09 |
| Model Number | 26003BA |
| Catalog Number | 26003BA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 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 | 2010-06-09 |