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 2016-12-22 for DISCOSCOPE, 25 DEGREE, 6.9MM SL, 207MM 892101254 89210.1254 manufactured by Richard Wolf Germany (gmbh).
[63102520]
Actual device returned to manufacturer on 12/13/2016. Investigation/evaluation currently in process. (b)(4) considers this report open, follow-up report to be submitted once investigation is complete. (b)(4). Evaluation of device inprocess.
Patient Sequence No: 1, Text Type: N, H10
[63102521]
Richard wolf (b)(4) was notified surgery was stopped while using device in question. The reason for stopping procedure is unknown at this time. Facility has been contact requesting additional information regarding the event, no response as of 12/22/2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611102-2016-00018 |
| MDR Report Key | 6198752 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-12-22 |
| Date of Report | 2016-11-25 |
| Date Mfgr Received | 2016-11-25 |
| Device Manufacturer Date | 2016-08-01 |
| Date Added to Maude | 2016-12-22 |
| 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 | DISCOSCOPE, 25 DEGREE, 6.9MM SL, 207MM |
| Generic Name | ENDOSCOPE |
| Product Code | GCM |
| Date Received | 2016-12-22 |
| Returned To Mfg | 2016-12-13 |
| Model Number | 892101254 |
| Catalog Number | 89210.1254 |
| 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 | 2016-12-22 |