Brand Name | REZUM |
Type of Device | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
300 boston scientific way |
marlborough MA 01752 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CORPORATION |
300 boston scientific way |
|
marlborough MA 01752 |
|
Manufacturer Contact |
alyson
harris
|
4100 hamline avenue north |
building c |
saint paul, MN 55112
|
|
MDR Report Key | 15743445 |
MDR Text Key | 303163753 |
Report Number | 2124215-2022-44106 |
Device Sequence Number | 1 |
Product Code |
GEI
|
UDI-Device Identifier | 00855357006003 |
UDI-Public | 00855357006003 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K180237 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
11/07/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | G2200 |
Device Catalogue Number | G2200 |
Device Lot Number | 0000003238 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/24/2022 |
Initial Date FDA Received | 11/07/2022 |
Supplement Dates Manufacturer Received | 10/24/2022
|
Supplement Dates FDA Received | 11/07/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/12/2016 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|