Brand Name | LEEP PRECISION INTG. SYS. |
Type of Device | LEEP PRECISION INTG. SYS. |
Manufacturer (Section D) |
COOPERSURGICAL, INC. |
75 corporate drive |
trumbull CT 06611 |
|
Manufacturer (Section G) |
COOPERSURGICAL, INC. |
75 corporate drive |
|
trumbull CT 06611 |
|
Manufacturer Contact |
peter
niziolek
|
75 corporate drive |
trumbull, CT 06611
|
|
MDR Report Key | 8378279 |
MDR Text Key | 137835151 |
Report Number | 1216677-2019-00106 |
Device Sequence Number | 1 |
Product Code |
HGI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K963348 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Biomedical Engineer
|
Remedial Action |
Repair |
Type of Report
| Initial |
Report Date |
02/28/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | LP-10-120 |
Device Catalogue Number | LP-10-120 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/13/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/13/2019 |
Initial Date FDA Received | 02/28/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/23/2018 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|