MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-29 for NEPHROSCOPE 20? 24FR. WL 224MM RIGID WITH LATERAL OCULAR LENS WORKING CHANNEL 8965.411 manufactured by Richard Wolf Gmbh.
[109636157]
Investigation / evaluation currently in process. Rw (b)(4) considers this report open, follow-up report to be submitted once investigation is complete. Richard wolf medical instruments corporation (rwmic) is submitting this report on behalf of richard wolf (b)(4). Rw (b)(4) is manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[109636158]
At the first ten minutes of the operation the nephroscope 8965. 411 was excellent and then we started the second operation and vision began to disappear gradually the same day. Unfortunately the operation was not completed. Manufactured date: 08 march 2018. Lot size: (b)(4) units. Purchase date: (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611102-2018-00010 |
| MDR Report Key | 7550175 |
| Date Received | 2018-05-29 |
| Date of Report | 2018-05-29 |
| Date of Event | 2018-04-17 |
| Date Mfgr Received | 2018-04-18 |
| Device Manufacturer Date | 2018-03-08 |
| Date Added to Maude | 2018-05-29 |
| 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. HEIKO SEIDER-BIEDERMANN |
| Manufacturer Street | PFORZHEIMER STRASSE 32 |
| Manufacturer City | KNITTLINGEN, GERMANY |
| Manufacturer G1 | RICHARD WOLF GMBH |
| Manufacturer Street | PFORZHEIMER STRASSE 32 |
| Manufacturer City | KNITTLINGEN, GERMANY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEPHROSCOPE 20? 24FR. WL 224MM RIGID WITH LATERAL OCULAR LENS WORKING CHANNEL |
| Generic Name | NEPHROSCOPE 20? 24FR WL224MM |
| Product Code | FGA |
| Date Received | 2018-05-29 |
| Model Number | 8965.411 |
| Catalog Number | 8965.411 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHEIMER STRABE 32 KNITTLINGEN, GERMANY 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-29 |