Device product
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes Model: 61-4005
Z-0503-2024
Product summary
- Event
- Event 93239
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 169 units
- Official record key
device-enforcement:Z-0503-2024
Official wording
Reason: Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure
Code information: UDI-DI:60888937016446 S/N: 313121, 313568
Distribution pattern: Nationwide Foreign: BELGIUM CANADA MALAYSIA NETHERLANDS SPAIN SWEDEN SWITZERLAND
Derived failure modes
-
Unknown
Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure