MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-02-05 for PKG., SDC ULTRA 0240050988 manufactured by Stryker Endoscopy San Jose.
[1334751]
Incorrect data saved. If two patient are loaded in the to do list, when the images are saved, the incorrect patient data is being saved with the images. Example: patient one's pictures are getting patient 2's data.
Patient Sequence No: 1, Text Type: D, B5
[8441323]
As part of a quality system improvement plan stryker corporation conducted a 2 year retrospective mdr review to ensure appropriate mdr reporting decisions. Events reported to stryker from 07/01/2006 to 07/01/2008 were the scope of this retrospective review. These events are being submitted under exemption (b)(4). There are 1 event(s) associated with this event type (malfunction) and product code lmb.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936485-2009-00437 |
| MDR Report Key | 1621846 |
| Report Source | 07 |
| Date Received | 2010-02-05 |
| Date of Report | 2010-02-05 |
| Date of Event | 2007-11-14 |
| Date Facility Aware | 2007-11-14 |
| Date Mfgr Received | 2007-11-14 |
| Date Added to Maude | 2010-10-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NILA PATEL |
| Manufacturer Street | 5900 OPTICAL CT. |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PKG., SDC ULTRA |
| Generic Name | INSTRUMENT |
| Product Code | LMD |
| Date Received | 2010-02-05 |
| Returned To Mfg | 2007-12-06 |
| Model Number | NA |
| Catalog Number | 0240050988 |
| Lot Number | NI |
| ID Number | LMB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY SAN JOSE |
| Manufacturer Address | SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-02-05 |