MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2020-02-20 for FISCHER CONE BIOP EX MED 900-151 manufactured by Coopersurgical, Inc..
[183911696]
Coopersurgical inc. Is currently investigating the reported complaint condition. Ref (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183911697]
Details surrounding event- during excision biopsy, wire broke and charred (blue) insulation on excisor. Surgeon reports a total of three incidents where wire has broken during procedure. This is first reported incident. Ref (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2020-00055 |
| MDR Report Key | 9734374 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2019-05-17 |
| Date Added to Maude | 2020-02-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PETER NIZIOLEK |
| Manufacturer Street | 50 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL, CT |
| Manufacturer Country | US |
| Manufacturer Phone | 6015200334 |
| Manufacturer G1 | COOPERSURGICAL, INC. |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL, CT |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FISCHER CONE BIOP EX MED |
| Generic Name | FISCHER CONE BIOP EX MED |
| Product Code | HGI |
| Date Received | 2020-02-20 |
| Model Number | 900-151 |
| Catalog Number | 900-151 |
| Lot Number | 264280 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 95 CORPORATE DRIVE TRUMBULL, CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-20 |