FDA Adverse Event
Other
Summary report: N
VIEWING WAND
MDR report key: 103687
·
Received July 7, 1997
Report
- Report Number
- 8022142-1997-00002
- Event Type
- Other
- Date Received
- July 7, 1997
- Date of Event
- May 22, 1997
- Report Date
- May 27, 1997
- Manufacturer
- I.S.G. TECHNOLOGIES, INC.
- Product Code
- HAW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE HOSPITAL COMPLAINED THAT THE CODMAN CMC3 BIPOLAR COAGULATOR WOULD LOSE POWER INTERMITTENTLY WHILE THE FREEHAND VIEWING WAND WAS POWERED ON. DURING THE REPORTED EVENT, A CRANIAL CASE FOR AN ANEURYSM RUPTURE, THE SITE EXPERIENCED A LOSS OF POWER TO THE COAGULATOR. OTHER COAGULATORS OF THE SAME TYPE WERE TRIED WITH THE SAME RESULT. ONCE THE VIEWING WAND WAS POWERED OFF, THE COAGULATORS BEGAN FUNCTIONING AS EXPECTED. NO COMPLICATIONS OR INJURIES RESULTED TO THE PATIENT. SUBSEQUENT INVESTIGATION REVEALED THAT THE PROBLEMS RESULTED FROM INFRARED INTERFERENCE, SINCE BOTH THE FREEHAND VIEWING WAND AND THE FOOT PEDAL CONTROL FOR THE COAGULATOR USE INFRARED SENSING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VIEWING WAND | IMAGE PROCESSING/SURGICAL NAVIGATION SYSTEM | HAW | I.S.G. TECHNOLOGIES, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other | CODMAN CMC3 BIPOLAR COAGULATOR 5/22/97 TO 5/22/97 |