FDA Adverse Event
Malfunction
Summary report: N
SCOPIS ENT SOFTWARE WITH TGS
MDR report key: 17548567
·
Received August 15, 2023
Report
- Report Number
- 3015967359-2023-01824
- Event Type
- Malfunction
- Date Received
- August 15, 2023
- Date of Event
- July 20, 2023
- Report Date
- September 6, 2023
- Manufacturer
- STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
- Product Code
- HAW
- UDI-DI
- 07613327413199
- PMA / PMN Number
- K221098
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
UPDATE: H3, H6 DEVICE EVALUATION: FOLLOW-UP REPORT SUBMITTED TO DOCUMENT THE DEVICE EVALUATION.
Description of Event or Problem · 0
PER THE CUSTOMER, THE DEVICE WAS INACCURATE BY 1-2 CM DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Description of Event or Problem · 0
PER THE CUSTOMER, THE DEVICE WAS INACCURATE BY 1-2 CM DURING A CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1736828 | SCOPIS ENT SOFTWARE WITH TGS | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP | UNKNOWN | 07613327413199 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |