Brand Name | TC LEXER SCISS NARR CVD 165MM |
Type of Device | GENERAL SURGICAL INSTRUMENTS |
Manufacturer (Section D) |
AESCULAP AG |
po box 40 |
tuttlingen, 78501 |
GM 78501 |
|
Manufacturer (Section G) |
AESCULAP AG |
po box 40 |
|
tuttlingen, 78501 |
GM
78501
|
|
Manufacturer Contact |
kerstin
rothweiler
|
po box 40 |
tuttlingen, 78501
|
GM
78501
|
|
MDR Report Key | 9202925 |
MDR Text Key | 163139723 |
Report Number | 9610612-2019-00719 |
Device Sequence Number | 1 |
Product Code |
LRW
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
10/17/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/17/2019 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | BC283R |
Device Catalogue Number | BC283R |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/25/2019 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 09/20/2019 |
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
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 63 YR |