MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-19 for KLEPPINGER 72-9704005714 manufactured by Richard Wolf Medical Instruments Corp..
[184482910]
Kleppinger instrument "will not work" per reporting staff. We are continuously sending them out for repair. The device in question is out for repair. No harm. Event reached patient, but no harm was evident. Name of operation: hysteroscopy with dilatation and curettage. Laparoscopy with co2 laser vaporization of endometriosis and myomectomy. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093859 |
| MDR Report Key | 9859882 |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-03-05 |
| Date Added to Maude | 2020-03-20 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | KLEPPINGER |
| Generic Name | COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES) |
| Product Code | HIN |
| Date Received | 2020-03-19 |
| Model Number | 72-9704005714 |
| Lot Number | E10894S10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |