MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-29 for HF RESECTION ELECTRODE- LOOP manufactured by Olympus Corporation Of The Americas.
[83876093]
Patient Sequence No: 1, Text Type: N, H10
[83876094]
Following the procedure the surgeon attempted to remove the scope. During removal, the filament tip of the cutting loop became dislodged in the patient's bladder. The surgeon was able to use the grasper on the scope to removed the dislodged filament. No foreign body was retained by the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6826972 |
| MDR Report Key | 6826972 |
| Date Received | 2017-08-29 |
| Date of Report | 2017-07-25 |
| Date of Event | 2017-02-17 |
| Report Date | 2017-07-25 |
| Date Reported to FDA | 2017-07-25 |
| Date Reported to Mfgr | 2017-07-25 |
| Date Added to Maude | 2017-08-29 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HF RESECTION ELECTRODE- LOOP |
| Generic Name | ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL |
| Product Code | NLW |
| Date Received | 2017-08-29 |
| Lot Number | P16Y0001 |
| ID Number | 24FR |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS CORPORATION OF THE AMERICAS |
| Manufacturer Address | 3500 CORPORATE PKWY. CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-29 |