FDA Adverse Event
Malfunction
Summary report: N
7MM EXTENDED LENGTH ENDOSCOPE
MDR report key: 18186221
·
Received November 21, 2023
Report
- Report Number
- 2242352-2023-00982
- Event Type
- Malfunction
- Date Received
- November 21, 2023
- Report Date
- February 26, 2024
- Manufacturer
- MAQUET CARDIOVASCULAR LLC
- Product Code
- GCJ
- UDI-DI
- 00607567700802
- PMA / PMN Number
- K014250
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
TRACKWISE#: (B)(4). FOR SERIAL # (B)(6), A LOT HISTORY SEARCH IS NOT APPLICABLE BECAUSE THIS IS A REUSABLE, OEM DEVICE. DUE TO THE AGE OF THE DEVICE, A C OF C IS NOT READILY AVAILABLE ON-SITE. H3 OTHER TEXT : DEVICE NOT RETURNED.
Additional Manufacturer Narrative · 0
TW ID# (B)(4). THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.
Description of Event or Problem · 0
N/A.
Description of Event or Problem · 0
THE HOSPITAL REPORTED THAT 7MM EXTENDED LENGTH ENDOSCOPE S/N (B)(6) USED FOR ENDOSCOPIC VEIN HARVESTING PROCEDURE, SCOPE SLIGHTLY BEND, LIGHT FIBRES SLIGHTLY BURNT AT THE CONNECTION PART AND PRESSURE POINTS. NO INJURY TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 917084 | 7MM EXTENDED LENGTH ENDOSCOPE | LAPAROSCOPE, GENERAL & PLASTIC SURGERY | GCJ | MAQUET CARDIOVASCULAR LLC | C-VH-1111 | 00607567700802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | UNKNOWN. |