MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2007-05-11 for manufactured by .
[19001242]
We did not receive any of the camera equipment or the scope used in this procedure back for eval. However, we did address various reprocessing issues (cleaning chemicals, flash sterilization, antifog solution, mixing sterilization modalities, etc. ) at this account in late 2006 that had a negative impact on their scope visuals. It is possible that the scope they were using was similarly affected. After this incident was reported, our sales rep brought in his sample scopes and procedures were completed with no grainy picture complaints.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610617-2007-00010 |
| MDR Report Key | 978644 |
| Report Source | 06,07 |
| Date Received | 2007-05-11 |
| Date Added to Maude | 2008-01-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | MITTLESTRASSE 8 POSTAFACH 230 |
| Manufacturer City | TUTTLINGEN 78503 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78503 |
| Manufacturer Phone | ** |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | HKK |
| Date Received | 2007-05-11 |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 946491 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-11 |