MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2015-12-29 for ENDOSCOPE, NEPHROSCOPE, 25? 8972.433 manufactured by Richard Wolf Gmbh.
[34647847]
The medical device shows signs of mechanical damage. The working channel was deformed. The optic was produced in june 2011 and delivered to richard wolf (b)(4) in july 2011. The resolve of the adhesive bond is caused at wear and tear due to numerous treatment cycles. The user is informed about a visual and functional check in chapter 7 in the ifu ("run through the checks before and after each use. "). By doing these checks deficiencies or damages can be identified to protect the user from applying this instrument. To our knowledge here is no explainable relationship between the loss of the lens and the removal of the kidney.
Patient Sequence No: 1, Text Type: N, H10
[34647848]
Richard wolf gmbh was informed in writing from richard wolf (b)(4) about the incident. The distal lens of the 8972,433 fell off during an intervention with ems lithoclast. The lens ended in the kidney of the patient. The kidney was removed completely.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611102-2015-00012 |
| MDR Report Key | 5333724 |
| Report Source | DISTRIBUTOR |
| Date Received | 2015-12-29 |
| Date of Report | 2015-11-27 |
| Date Mfgr Received | 2015-11-27 |
| Device Manufacturer Date | 2011-06-09 |
| Date Added to Maude | 2015-12-29 |
| 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. OLIVER EHRLICH |
| Manufacturer Street | 32 PFORZHEIMER STREET |
| Manufacturer City | KNITTLINGEN, 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal | 75438 |
| Manufacturer Phone | 043351013 |
| Manufacturer G1 | RICHARD WOLF GMBH |
| Manufacturer Street | 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 | ENDOSCOPE, NEPHROSCOPE, 25? |
| Generic Name | NEPHROSCOPE |
| Product Code | GCM |
| Date Received | 2015-12-29 |
| Model Number | 8972.433 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | 32 PFORZHEIMER STREET KNITTLINGEN, 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2015-12-29 |