MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-10 for SHEATH, RESECTOSCOPE, PROFILE 8655.384 manufactured by Richard Wolf Gmbh.
[22947590]
Facility notified a (b)(4) sales representative that during a procedure the ceramic tip of the device in question chipped and chip landed inside of patient. Doctor was able to easily retrieve chip and completed procedure as scheduled. No injury to patient or staff reported. An investigation will not be completed by (b)(4). If and when device is received by (b)(4) it will be sent to manufacturer (rw(b)(4)) for investigation. No other (b)(4) complaints on this device type in the last three years. Request for additional information, no response as of 08/10/2015. Richard wolf considers this matter closed. However, in the event we receive additional information, we will provide fda with the follow-up information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2015-00027 |
| MDR Report Key | 4992280 |
| Date Received | 2015-08-10 |
| Date of Report | 2015-07-30 |
| Date of Event | 2015-07-29 |
| Date Facility Aware | 2015-07-30 |
| Report Date | 2015-08-10 |
| Date Reported to FDA | 2015-08-10 |
| Date Reported to Mfgr | 2015-08-10 |
| Date Added to Maude | 2015-08-11 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 Street | 353 CORPORATE WOODS PKWY. |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Manufacturer Street | 353 CORPORATE WOODS PKWY. |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60061 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHEATH, RESECTOSCOPE, PROFILE |
| Generic Name | SHEATH |
| Product Code | FDC |
| Date Received | 2015-08-10 |
| Model Number | 8655.384 |
| Catalog Number | 8655.384 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHEIMER STRABE 32 GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-10 |