GYN DISPOSABLES TENACULUM 356T (COMPONENT OF GYN DISPOSABLES 935K IUD INSERTION
Received Sep 21, 2012 · Event occurred Mar 28, 2012
Report MW5027079 · MDR key 2766609
Device
Generic name
Tenaculum
Manufacturer
Gyn DisposablesModel number
NACatalog number
356T
Lot number
935K: 61172179
Product problems
- Break
Patient
UNK
- Hemorrhage/Blood Loss/Bleeding
- Laceration(s)
Narrative
Description of Event or Problem
NURSE PRACTITIONER SAYS THAT BOTH OF THE TENACULUM TIPS AND THE LOCKING RACHET BROKE DURING AN IUD PROCEDURE. SHE BELIEVED THE SIZE OF THE BROKEN TIPS WERE APPROXIMATELY 5MM FOR THE LEFT TIP AND 2 TO 3MM FOR THE RIGHT TIP. ONE TIP REMAINED LODGED IN PT; OTHER TIP WAS RETRIEVED. NURSE PRACTITIONER SAID THAT A LACERATION WAS IN BACK OF CERVIX FROM 4 O'CLOCK TO 8 O'CLOCK POSITION. PT HAD SLIGHT BLEEDING. PT LEFT, RESCHEDULED APPOINTMENT, CHECKED A WEEK LATER, AND EVERYTHING WAS FINE. NURSE PRACTITIONER SAID DATE OF OCCURRENCE WAS (B)(6) 2012. GYN DISPOSABLES WAS NOT INFORMED OF OCCURRENCE UNTIL (B)(6) 2012, DURING A SALES CALL. PRODUCT NOT AVAILABLE FOR EVAL.