MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-05-16 for GRIP-TIP URETHRAL SUTURE GUIDE * U515 manufactured by Greenwald Surgical Co., Inc..
[51718]
Instrument non-functional. When cleaning instrument, it was not working properly (unable to open & close instrument). Upon disassembly, instrument found full of blood & tissue. Disassembled instrument. Mfr's instructions are that instrument is not to be disassembled, even for cleaning. Mfr's instructions followed for cleaning & despite following the instructions, blood & tissue remained. Unable to sterilize & clean instrument following instructions from co. Now have an instrument unable to use. This instrument was used on at least 17 pts. Hosp attempting to learn of any ill effects/infections pts might have sustained as a result of this instrument.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 91668 |
| MDR Report Key | 91668 |
| Date Received | 1997-05-16 |
| Date of Report | 1997-05-08 |
| Date of Event | 1997-05-02 |
| Date Facility Aware | 1997-05-02 |
| Report Date | 1997-05-07 |
| Date Added to Maude | 1997-05-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRIP-TIP URETHRAL SUTURE GUIDE |
| Generic Name | GREENWALD PROSTATE SOUND |
| Product Code | FBX |
| Date Received | 1997-05-16 |
| Model Number | * |
| Catalog Number | U515 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 90555 |
| Manufacturer | GREENWALD SURGICAL CO., INC. |
| Manufacturer Address | 2688 DE KALB ST. LAKE STATION IN 46405 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-05-16 |