MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-04 for KLEPPINGER PART # 72-970 manufactured by Unk.
[182530353]
Kleppinger did not work. Per instrument mgr, we have had multiple problems with the kleppingers and we constantly have to send them out for repair. This is kleppinger manufactured by millennium, part #72-970, lot# e1018; millennium. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093541 |
| MDR Report Key | 9793407 |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-19 |
| Date Added to Maude | 2020-03-05 |
| 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 | COAGLATION - CUTTER, ENDOSCOPIC, BIPOLAR AND ACCESSORIES |
| Product Code | HIN |
| Date Received | 2020-03-04 |
| Model Number | PART # 72-970 |
| Lot Number | E1018 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-04 |