MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-03-22 for KARL STORZ 22220150-3 manufactured by Karl Storz Imaging.
[17485323]
It was alleged that control button on camera came off into the sterile field during procedure. Or personnel report that they spent 1 hr searching for the button. They found the button in the folds of the pt drape. Procedure was completed with no impact other than delay to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020550-2008-00007 |
| MDR Report Key | 1027742 |
| Date Received | 2008-03-22 |
| Date of Report | 2008-03-20 |
| Date of Event | 2008-02-25 |
| Date Facility Aware | 2008-02-25 |
| Report Date | 2008-03-20 |
| Date Reported to FDA | 2008-03-20 |
| Date Reported to Mfgr | 2008-03-20 |
| Date Added to Maude | 2008-04-14 |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARL STORZ |
| Generic Name | HD IMAGE 1 CAMERA |
| Product Code | FWG |
| Date Received | 2008-03-22 |
| Model Number | 22220150-3 |
| Catalog Number | 22220150-3 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 994309 |
| Manufacturer | KARL STORZ IMAGING |
| Manufacturer Address | 175B CREMONA DR. GOLETA CA 93117 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-03-22 |