MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-22 for BIPOLAR CUTTING LOOP 24FR .35MM 27040-GPV-24-CH manufactured by Karl Storz Endoscopy-america, Inc..
[4140880]
1) cutting loop from endoscope broke off from the rest of the device. Tip was retrieved from the bladder with no known harm to patient. ======================manufacturer response for disposable electrosurgical unit probe, bipolar cutting loop (per site reporter). ======================will call today and return device if requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3575728 |
| MDR Report Key | 3575728 |
| Date Received | 2013-11-22 |
| Date of Report | 2013-11-22 |
| Date of Event | 2013-11-21 |
| Report Date | 2013-11-22 |
| Date Reported to FDA | 2013-11-22 |
| Date Reported to Mfgr | 2014-01-15 |
| Date Added to Maude | 2014-01-15 |
| 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 | 3 |
| 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 | BIPOLAR CUTTING LOOP 24FR .35MM 27040-GPV-24-CH |
| Generic Name | ENDOSURGICAL UNIT PROBE |
| Product Code | HIN |
| Date Received | 2013-11-22 |
| Model Number | 27040-GPV-24-CH |
| Catalog Number | 27040-GPV-24-CH |
| Lot Number | ORIGINAL PACKAGING NOT AVAIL |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| Manufacturer Address | 2151 E. GRAND AVENUE EL SEGUNDO CA 90245501 US 90245 5017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-22 |