FDA Adverse Event
Malfunction
Summary report: N
HEMOPRO2 EXTENSION CABLE
MDR report key: 12024604
·
Received June 18, 2021
Report
- Report Number
- 2242352-2021-00489
- Event Type
- Malfunction
- Date Received
- June 18, 2021
- Date of Event
- May 28, 2021
- Report Date
- July 27, 2021
- Manufacturer
- MAQUET CARDIOVASCULAR LLC
- Product Code
- GEI
- UDI-DI
- 00607567700925
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
TRACKWISE # (B)(4). TREND ANALYSIS: (4110/213/67) THE OVERALL 24 MONTH PRODUCT COMPLAINT TREND DATA FOR THE PERIOD JUL 2019 THROUGH JUN 2021 WAS REVIEWED. THERE WERE NO TRIGGERS IDENTIFIED FOR THE REVIEW PERIOD.
Additional Manufacturer Narrative · 1
TRACKWISE ID # (B)(4). SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP.
Description of Event or Problem · 1
RELATED TO (B)(4). THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING HEMOPRO2 EXTENSION CABLE, THERE WAS A LOT OF SMOKE COMING OUT THE CORD. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 919683 | HEMOPRO2 EXTENSION CABLE | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | MAQUET CARDIOVASCULAR LLC | HEMOPRO2 EXTENSION CABLE | 00607567700925 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |