FDA Adverse Event
Malfunction
Summary report: N
ADVINCULA DELINEATOR UTERINE MANIPULATOR WITH 3.5 CM ULTEM KOH-EFFICIENT
MDR report key: 25306943
·
Received May 27, 2026
Report
- Report Number
- 1216677-2026-00038
- Event Type
- Malfunction
- Date Received
- May 27, 2026
- Date of Event
- April 29, 2026
- Report Date
- May 26, 2026
- Manufacturer
- COOPERSURGICAL, INC.
- Product Code
- HEW
- UDI-DI
- 00888937012750
- PMA / PMN Number
- K143650
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DEVICE LOCATION IS UNKNOWN. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING A LAPERSCOPIC HYSTERECTOMY, THE SURGEON INSERTED THE DELINEATOR AND SNAPPED THE POSITION LOCK IN PLACE. DURING THE PROCEDURE, THE 3RD YEAR RESIDENT PHYSICIAN WAS PUSHING CEPHALAD VERY FIRMLY ON THE DELINEATOR. THE DELINEATOR TIP PERFORATED THE UTERUS BETWEEN THE FUNDUS AND CERVIX. THE RESIDENT PHYSICIAN SAID THE POSITION LOCK SLIPPED, CAUSING THE COLPOTOMY CUP TO SHIFT, RESULTING IN A PERFORATION. NO INJURIES RESULTED. PROCEDURE RESUMED. AD750-KE35 UTERINE MANIPULATOR 2026-05-0000074.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 202375 | ADVINCULA DELINEATOR UTERINE MANIPULATOR WITH 3.5 CM ULTEM KOH-EFFICIENT | UTERINE MANIPULATOR, SINGLE-USE | HEW | COOPERSURGICAL, INC. | AD750-KE35 | UNKNOWN | 00888937012750 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |