Device product
TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808
Z-1467-2022
Product summary
- Firm
- Covidien Llc
- Event
- Event 90519
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 33 units
- Official record key
device-enforcement:Z-1467-2022
Official wording
Reason: Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.
Code information: UDI-Device Identifier (GTIN/UPN) 10884521749931 Serial Number: YF1120, YF1126, YF1127, YF1128, YF1129, YF1130, YF1131, YF1133, YF1134, YF1135, YF1137, YF1138, YF1139, YF1140, YF1141, YF1142, YF1150, YF1152, YF1154, YF1156, YF1157, YF1158, YF1161, YF1163, YF1166, YF1167, YF1168, YF1169, YF1172, YF1175, YF1176, YF1177, YF1182
Distribution pattern: AZ CA CO IL KS MA MI MN MO NY OK PA TN TX TX WA Foreign: United Kingdom Ireland Netherlands Reunion Spain
Derived failure modes
-
Unknown
Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.