MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-20 for ENDOSCOPIC LIGHT SOURCE 5142.002 manufactured by Richard Wolf Germany (gmbh).
[70627612]
Actual device has not been returned but is currently in transit to manufacturer. Investigation/evaluation of device not yet initiated. Review of production records currently in process. (b)(4) considers this report open, follow-up report to be submitted once investigation is complete. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[70627613]
Richard wolf (b)(4) was notified that during a procedure the device in question stopped and an error message displayed on screen. A back up device was not readily available and procedure stopped and rescheduled. Delay in procedure may have placed patient at risk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611102-2017-00004 |
| MDR Report Key | 6417335 |
| Date Received | 2017-03-20 |
| Date of Report | 2017-02-20 |
| Date of Event | 2017-02-20 |
| Date Mfgr Received | 2017-02-20 |
| Device Manufacturer Date | 2014-02-19 |
| Date Added to Maude | 2017-03-20 |
| 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 Contact | MR. OLIVER EHRLICH |
| Manufacturer Street | REGISTRATION NUMBER 9611102 32 PFORZHEIMER STREET |
| Manufacturer City | KNITTLINGEN, 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal | 75438 |
| Manufacturer Phone | 043351013 |
| Manufacturer G1 | RICHARD WOLF GERMANY (RWGMBH) |
| Manufacturer Street | REGISTRATION NUMBER 9611102 32 PFORZHEIMER STREET |
| Manufacturer City | KNITTLINGEN, 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 75438 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ENDOSCOPIC LIGHT SOURCE |
| Generic Name | LIGHT SOURCE |
| Product Code | GCT |
| Date Received | 2017-03-20 |
| Model Number | 5142.002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GERMANY (GMBH) |
| Manufacturer Address | REGISTRATION #9611102 32 PFORZHEIMER STREET KNITTLINGEN, 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-20 |