MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-03-24 for 27/28FR RESECTOSCOPE TIMBERLAKE OBTURATOR 0502880425 manufactured by Stryker Endoscopy San Jose.
[18910618]
It was reported that perforation holes at the end of the resectoscope perform like a cheese grater. Allegedly, the ridge at the end of the timberlake is causing abrasions and scratches of the urethra.
Patient Sequence No: 1, Text Type: D, B5
[19034844]
Additional info will be provided once investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936485-2009-00024 |
| MDR Report Key | 1351667 |
| Report Source | 07 |
| Date Received | 2009-03-24 |
| Date of Report | 2009-02-23 |
| Date of Event | 2009-02-23 |
| Date Mfgr Received | 2009-02-23 |
| Date Added to Maude | 2009-03-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NILA PATEL |
| Manufacturer Street | 5900 OPTICAL CT. |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | STRYKER ENDOSCOPY |
| Manufacturer Street | 5900 OPTICAL CT. |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95138 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 27/28FR RESECTOSCOPE TIMBERLAKE OBTURATOR |
| Generic Name | OBTURATOR |
| Product Code | FEC |
| Date Received | 2009-03-24 |
| Catalog Number | 0502880425 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY SAN JOSE |
| Manufacturer Address | SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-03-24 |