MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-26 for LEEP SYSTEM 1000 ESU GEN. 52969 manufactured by Coopersurgical, Inc..
[184432989]
Coopersurgical inc. Is currently investigating the reported condition.
Patient Sequence No: 1, Text Type: N, H10
[184432990]
Report forwarded by csi service & repairs- the repair log/authorization form stated- "need checked after incident". Please note incident was not reported on the authorization form as at time on complaint initiation , however excess bleeding was notated. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2020-00060 |
| MDR Report Key | 9758680 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-01-16 |
| Date Added to Maude | 2020-02-26 |
| 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 |
| 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 | LEEP SYSTEM 1000 ESU GEN. |
| Generic Name | LEEP SYSTEM 1000 ESU GEN. |
| Product Code | HGI |
| Date Received | 2020-02-26 |
| Model Number | 52969 |
| Catalog Number | 52969 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-26 |