TRUCLEAR
Report
- Report Number
- 1282497-2025-00367
- Event Type
- Malfunction
- Date Received
- May 29, 2025
- Date of Event
- May 5, 2025
- Report Date
- September 12, 2025
- Manufacturer
- COVIDIEN MANSFIELD
- Product Code
- HIH
- UDI-DI
- 10884521746633
- PMA / PMN Number
- K180496
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
D10 CONCOMITANT PRODUCTS: SOFT TIS SHAVER MINI 72202536 TRUCLEAR - 72202536, LOT# 5822893 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ADDITIONAL INFORMATION: G3, H3, H6. H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS NOT RETURNED, BUT A PHOTO WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE TWO PHOTOS SHOWS SEVERAL DARK OBJECTS THAT ARE NOT IDENTIFIABLE. ALSO, THERE IS AN UNIDENTIFIED INSTRUMENT IN ONE OF THE PHOTOS. IT WAS REPORTED THAT THE DEVICE WAS NOT CLEANED APPROPRIATELY. THE REPORTED ISSUE WAS PLAUSIBLE. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. IT WAS ALSO REPORTED THAT THE COMPONENT WAS DISENGAGED. THE REPORTED ISSUE COULD NOT BE CONFIRMED THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. THE INSTRUCTIONS INCLUDED WITH THIS DEVICE PROVIDE THE FOLLOWING GUIDANCE: UNDER 32-40°C (90-104°F) RUNNING TAP WATER, RINSE THE HYSTEROSCOPE AND DISASSEMBLED COMPONENTS TO REMOVE ALL BLOOD AND SURGICAL DEBRIS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ADDITIONAL INFORMATION: B5, G3, H6. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ADDITIONAL INFORMATION: G3, H6 ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON WAS CONDUCTING A HYSTEROSCOPY USING OUR TRUCLEAR SYSTEM AND HYSTEROSCOPE INITIALLY IN IDENTIFYING PATHOLOGY. AS DETERMINED TO USE THE SOFT TISSUE MINI SHAVER TO REMOVE AND BIOPSY POLYP, UPON ENTERING THE SHAVER INTO AND THROUGH THE HYSTEROSCOPE IT BECAME VISIBLE THAT A FOREIGN OBJECT WAS PUSHED OUT AND IMMEDIATELY DETECTED AND REMOVED BY THE SURGEON. THERE WAS NO PATIENT INJURY.
ACCORDING TO THE REPORTER, DURING HYSTEROSCOPY POLYPECTOMY PROCEDURE, THE SURGEON WAS CONDUCTING A HYSTEROSCOPY USING THE DEVICE AND HYSTEROSCOPE INITIALLY IN IDENTIFYING PATHOLOGY. AS DETERMINED TO USE THE SOFT TISSUE MINI SHAVER TO REMOVE AND BIOPSY POLYP, UPON ENTERING THE SHAVER INTO AND THROUGH THE HYSTEROSCOPE IT BECAME VISIBLE THAT A FOREIGN OBJECT WAS PUSHED OUT AND IMMEDIATELY DETECTED AND REMOVED BY THE SURGEON. A PIECE FELL INTO THE PATIENT'S CAVITY AND IT WAS RETRIEVED. THERE WAS NO X-RAY PERFORMED, AND NO ADDITIONAL MEDICAL PROCEDURE WAS NEEDED. IT WAS CONFIRMED VIA PATHOLOGY REPORT RECEIVED THAT FOREIGN BODY WAS DETERMINED TO BE AN ¿ENDOMETRIAL POLYP WITH DEGENERATIVE CHANGES¿ AND HAD FURTHER INDICATED THAT IT WAS ATTRIBUTED TO ¿WASN¿T CLEANED APPROPRIATELY¿. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 36305 | TRUCLEAR | HYSTEROSCOPE (AND ACCESSORIES) | HIH | COVIDIEN MANSFIELD | 72204878 | 10884521746633 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |