Brand Name | PKG; PNEUMO SURE XL HIGH FLOW INSUFFLATOR |
Type of Device | INSUFFLATOR, LAPAROSCOPIC |
Manufacturer (Section D) |
STRYKER ENDOSCOPY-SAN JOSE |
5900 optical court |
san jose CA 95138 |
|
Manufacturer (Section G) |
STRYKER ENDOSCOPY-SAN JOSE |
5900 optical court |
|
san jose CA 95138 |
|
Manufacturer Contact |
chester
rebugio
|
5900 optical court |
san jose, CA 95138
|
4087542000
|
|
MDR Report Key | 18923327 |
MDR Text Key | 337894579 |
Report Number | 0002936485-2024-00236 |
Device Sequence Number | 1 |
Product Code |
HIF
|
UDI-Device Identifier | 07613327063295 |
UDI-Public | 07613327063295 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K063367 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/18/2024 |
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 Catalogue Number | 0620040610 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
02/28/2024
|
Initial Date FDA Received | 03/18/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |