FDA Adverse Event
Malfunction
Summary report: N
SCOPIS ENT SOFTWARE WITH TGS
MDR report key: 15840139
·
Received November 21, 2022
Report
- Report Number
- 3015967359-2022-02330
- Event Type
- Malfunction
- Date Received
- November 21, 2022
- Date of Event
- October 25, 2022
- Report Date
- March 14, 2023
- Manufacturer
- STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
- Product Code
- PGW
- UDI-DI
- 07613327413199
- PMA / PMN Number
- K161491
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE LOG FILES WERE NOT RETURNED FOR EVALUATION; THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED FOR THE EVENT. H3 OTHER TEXT : ONLY SESSION AND AUDIT LOGS WERE PROVIDED, NOT DEVICE FILES.
Description of Event or Problem · 0
PER THE CUSTOMER, THE DEVICE WAS INACCURATE BY 3MM DURING A SURGICAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY.
Description of Event or Problem · 0
PER THE CUSTOMER, THE DEVICE WAS INACCURATE BY 3MM DURING A SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1758709 | SCOPIS ENT SOFTWARE WITH TGS | NEUROLOGICAL STEREOTAXIC INSTRUMENT | PGW | STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP | 8000-020-002 | VERSION UNKNOWN | 07613327413199 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |