FDA Adverse Event
Injury
Summary report: N
STANDARD-OBTURATOR
MDR report key: 17210132
·
Received June 27, 2023
Report
- Report Number
- 9610617-2023-00818
- Event Type
- Injury
- Date Received
- June 27, 2023
- Date of Event
- February 14, 2018
- Report Date
- June 19, 2023
- Manufacturer
- KARL STORZ SE & CO. KG
- Product Code
- HET
- PMA / PMN Number
- K946359
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BELATED EVALUATION AND REPORTING OF THIS COMPLAINT WAS DONE DURING RETROSPECTIVE REVIEW AS PART OF CAPA 20-0074 CORRECTIVE ACTION 6. THE CUSTOMER PROVIDED THE ENTIRE RESECTOSCOPE. ALL COMPONENTS ARE ACCORDING TO SPECIFICATION. NO ERROR COULD BE FOUND. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4)).
Description of Event or Problem · 0
IT WAS REPORTED THAT THERE WAS EVENT WITH AN ENDOMETRIAL ABLATION RESECTOSCOPE ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT SUFFERED TISSUE DAMAGE - BURN AT THE VAGINAL INTROITS. AREA ALSO BLISTERED. PATIENT INFORMED OF ALL WHAT HAPPENED. ADVISE RE WOUND CARE TO AREAS GIVEN. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 929797 | STANDARD-OBTURATOR | STANDARD-OBTURATOR | HET | KARL STORZ SE & CO. KG | 26040OC | UU01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other | 26050CA INNER SHEATH FOR RESECTOSCOPE, LOT TU01.| 26050E WORKING ELEMENT, LOT SU03.| 26050G CUTTING LOOP, 26 FR., LOT SU01.| 26050L COAGULATION ELECTRODE, 26 FR., LOT: SU01.| 26050N COAGULATING ELECTRODE, 24 FR., LOT RU02.| 26050SC RESECTOSCOPE SHEATH, 26 FR., LOT UU01.| 26050XH COAGULATING NEEDLE ELECTRODE, LOT RU01.| 26105FA HOPKINS TELESCOPE 12°, 4 MM, 30 CM, 1202V2.| 277 UNIPOLAR HIGH FREQUENCY CORD, 300 CM, LOT RU01. |