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 2020-02-10 for FISCHER CONE BIOP EX MED 900-151 manufactured by Coopersurgical, Inc..
[182457196]
Coopersurgical inc. Is currently investigating the reported complaint condition. Once the investigation is completed a follow-up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[182457197]
Per mw5091773 received - report stated " patient consented for a laparoscopic tubal litigation, removal of iud and leep of the cervix, during the leep, the tips of the electrode came off the electrode to the patient uterus. A hysterectomy was done to locate the tip of the electrode and it was retrieved. Please see attached mw5091773 for details. Update -01. 29. 2020 - initiated follow-up reviewed extra step to complete procedure was hysteroscopy not hysterectomy as reported on mw5091773 (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2020-00002 |
| MDR Report Key | 9687490 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-10 |
| Date of Event | 2019-11-12 |
| Date Mfgr Received | 2020-01-10 |
| Device Manufacturer Date | 2018-05-18 |
| Date Added to Maude | 2020-02-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | COOPERSURGICAL, INC. |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06611 |
| 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 | 2020-02-10 |
| Model Number | 900-151 |
| Catalog Number | 900-151 |
| Lot Number | 238680 |
| 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 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-10 |