Brand Name | M3-GOLD AUTOCLAVABLE LATERAL TELESCOPE 70 DEG |
Type of Device | CYSTOSCOPE |
Manufacturer (Section D) |
GYRUS ACMI, INC |
136 turnpike road |
southborough MA 01772 |
|
Manufacturer Contact |
kenneth
pittman
|
93 north pleasant st. |
norwalk, OH 44857
|
9013785969
|
|
MDR Report Key | 10395616 |
MDR Text Key | 203529085 |
Report Number | 1519132-2020-00049 |
Device Sequence Number | 1 |
Product Code |
FAJ
|
Combination Product (Y/N) | N |
Reporter Country Code | US |
PMA/PMN Number | K890328 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
COMPANY REPRESENTATIVE,USER F |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
09/30/2020 |
1 Device Was Involved in the Event |
|
0 PatientS WERE Involved in the Event: | |
Date FDA Received | 08/12/2020 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
HEALTH PROFESSIONAL
|
Device MODEL Number | M3-70A |
Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
Date Returned to Manufacturer | 07/16/2020 |
Is The Reporter A Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Event Location |
No Information
|
Date Manufacturer Received | 09/02/2020 |
Was Device Evaluated By Manufacturer? |
Yes
|
Is The Device Single Use? |
No
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
|
|