MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-29 for SCHNEIDE-ELEKTRODE BIPO 26CH 12/30 4624-1313 2624-1313 manufactured by Richard Wolf Gmbh.
[146692012]
During cystoscopy, transurethral resection of prostate with bipolar loop, the loop (tip) of the 26fr bipolar electrode broke off inside the pt. Surgeon unable to visualize the broken piece inside the pt, using the cystoscope. Removed remainder of electrode from sterile field, placed in biohazard bag with package. X-ray taken negative for foreign body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5087014 |
| MDR Report Key | 8655495 |
| Date Received | 2019-05-29 |
| Date of Report | 2019-05-14 |
| Date of Event | 2019-05-14 |
| Date Added to Maude | 2019-05-30 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SCHNEIDE-ELEKTRODE BIPO 26CH 12/30 |
| Generic Name | LOOP ELECTRODE ELECTROSURGICAL |
| Product Code | JOS |
| Date Received | 2019-05-29 |
| Model Number | 4624-1313 |
| Catalog Number | 2624-1313 |
| Lot Number | 4500242351 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-29 |