MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2016-10-27 for PANOVIEW OPERATING TELESCOPE 8962433 manufactured by Richard Wolf Germany (gmbh).
[58606814]
Actual device being returned to manufacturer by user facility, sent on 10/14/2016 via (b)(4). Investigation/evaluation 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
[58606815]
Richard wolf (b)(4) was notified by user facility that during a lithotripsy procedure, the view became blurry while looking through nephoscope. Nephoscope was taken out of patient and examined, staff found the 2mm lens of nephroscope missing. In an effort to locate the lens an x-ray of the kidney, ureter, and bladder (kub) as well as a ct of lower abdomen was performed on the patient on the day of the procedure. Facility sent device to manufacture on 10/14/2016 via (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611102-2016-00016 |
| MDR Report Key | 6061598 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-10-27 |
| Date of Report | 2016-10-03 |
| Date of Event | 2016-09-29 |
| Date Mfgr Received | 2016-10-03 |
| Device Manufacturer Date | 2011-09-19 |
| Date Added to Maude | 2016-10-27 |
| 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 | 32 PFORZHEIMER STREET |
| Manufacturer City | KNITTLINGEN, 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal | 75438 |
| Manufacturer Phone | 043351013 |
| Manufacturer G1 | RICHARD WOLF GERMANY (GMBH) |
| Manufacturer Street | REGISTRATION #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 | 3 |
| Brand Name | PANOVIEW OPERATING TELESCOPE |
| Generic Name | RIGID NEPHOSCOPE |
| Product Code | GCM |
| Date Received | 2016-10-27 |
| Returned To Mfg | 2016-10-14 |
| Model Number | 8962433 |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 1. Other | 2016-10-27 |