FDA Adverse Event
Malfunction
Summary report: N
FOREIGN BODY FORCEPS, 28 CM
MDR report key: 24765022
·
Received April 2, 2026
Report
- Report Number
- 9610617-2026-00717
- Event Type
- Malfunction
- Date Received
- April 2, 2026
- Date of Event
- March 18, 2026
- Report Date
- April 2, 2026
- Manufacturer
- KARL STORZ SE & CO. KG
- Product Code
- OCZ
- UDI-DI
- 04048551079119
- PMA / PMN Number
- K950434
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE WILL NOT BE FORWARDED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE TECH IN THE ROOM DID TEST PRIOR TO IT GOING IN THE PATIENT AND IT WAS OPENING AND CLOSING FINE, ONCE INSIDE IT BROKE WITH JAWS OPEN SO SHE REMOVED THE HANDLE AND USED ANOTHER GRASPER TO PULL FRAYED ENDS AND THAT CLOSED THE JAWS AND SHE SLOWLY PULLED IT ALL OUT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 831085 | FOREIGN BODY FORCEPS, 28 CM | FOREIGN BODY FORCEPS, 28 CM | OCZ | KARL STORZ SE & CO. KG | 27071TJ | UQ01 | 04048551079119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |