Brand Name | ENDO DISSECT |
Type of Device | MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED |
Manufacturer (Section D) |
US SURGICAL PUERTO RICO |
201 sabanetas industrial park |
ponce PR 00716 4401 |
|
Manufacturer (Section G) |
US SURGICAL PUERTO RICO |
201 sabanetas industrial park |
|
ponce PR 00716 4401 |
|
Manufacturer Contact |
lisa
hernandez
|
60 middletown ave |
north haven, CT 06473
|
2034925563
|
|
MDR Report Key | 7620613 |
MDR Text Key | 111740751 |
Report Number | 2647580-2018-03020 |
Device Sequence Number | 1 |
Product Code |
GET
|
UDI-Device Identifier | 20884523000747 |
UDI-Public | 20884523000747 |
Combination Product (y/n) | N |
Reporter Country Code | IT |
PMA/PMN Number | K904578 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
11/29/2018 |
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 Expiration Date | 10/31/2022 |
Device Model Number | 176645 |
Device Catalogue Number | 176645 |
Device Lot Number | P7K1584X |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/20/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/05/2018 |
Initial Date FDA Received | 06/20/2018 |
Supplement Dates Manufacturer Received | 09/08/2018 11/05/2018
|
Supplement Dates FDA Received | 09/28/2018 11/29/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/26/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Age | 55 YR |
Patient Weight | 65 |