Brand Name | ENDOWRIST |
Type of Device | FENESTRATED BIPOLAR FORCEPS |
Manufacturer (Section D) |
INTUITIVE SURGICAL, INC |
3410 central expressway |
santa clara CA |
|
Manufacturer (Section G) |
INTUITIVE SURGICAL, INC |
3410 central expressway |
|
santa clara CA |
|
Manufacturer Contact |
izabel
nielson
|
3410 central expressway |
santa clara, CA
|
4085232100
|
|
MDR Report Key | 15128546 |
MDR Text Key | 296848142 |
Report Number | 2955842-2022-13229 |
Device Sequence Number | 1 |
Product Code |
NAY
|
UDI-Device Identifier | 00886874119808 |
UDI-Public | (01)00886874119808(10)K11211004 |
Combination Product (y/n) | N |
PMA/PMN Number | K131861 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
06/30/2022 |
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 | 471205-17 |
Device Catalogue Number | 471205 |
Device Lot Number | K11211004 0101 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/22/2022 |
Initial Date Manufacturer Received |
06/30/2022 |
Initial Date FDA Received | 07/29/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/30/2021 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
Treatment | DA VINCI INSTRUMENTS AND ACCESSORIES |
Patient Sex | Male |
Patient Ethnicity | Non Hispanic |
Patient Race | Asian |