FDA Adverse Event
Injury
Summary report: N
LEEP SYSTEM 1000 ESU GEN.
MDR report key: 5614857
·
Received April 28, 2016
Report
- Report Number
- 1216677-2016-00034
- Event Type
- Injury
- Date Received
- April 28, 2016
- Date of Event
- April 20, 2016
- Report Date
- November 9, 2016
- Manufacturer
- COOPERSURGICAL, INC.
- Product Code
- HGI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
REF (B)(4). THIS CONCLUDES COOPERSURGICAL' S ROOT CAUSE INVESTIGATION. COOPERSURGICAL, INC. WILL CONTINUE TO MONITOR THE COMPLAINT CONDITION FOR TENDING AND SAFETY.
Additional Manufacturer Narrative · 1
COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE DEVICE INVOLVED IN THE COMPLAINT WAS RETURNED BY THE CUSTOMER AND IS BEING EVALUATED. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. (B)(4).
Description of Event or Problem · 1
REVIEW OF REPAIR ORDER LOG (B)(4). "COULD ONLY GIVE US DETAIL THAT THE PATIENT WAS LACERATED AND THEY ARE NOT SURE IF THE LEEP DID THAT." (B)(4).
Description of Event or Problem · 1
REVIEW OF REPAIR ORDER LOG (B)(4). "COULD ONLY GIVE US DETAIL THAT THE PATIENT WAS LACERATED AND THEY ARE NOT SURE IF THE LEEP DID THAT." (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 270476 | LEEP SYSTEM 1000 ESU GEN. | LEEP SYSTEM 1000 ESU GEN. | HGI | COOPERSURGICAL, INC. | 52969 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |