PUNCH,BIOPSY,CERVICAL,TISCHLER,3X7,9"
Received May 22, 2025 · Event occurred Apr 16, 2025
Report 1417592-2025-00248 · MDR key 22070288
Device
Generic name
Punch,biopsy,cervical,tischler,3x7,9"
Manufacturer
Medline Industries, LpCatalog number
MDS7063101
Product problems
- Difficult to Open or Close
- Difficult to Open or Close
Patient
27 YR · Female
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 DURING A "COLPOSCOPY" THERE WAS "POSSIBLE INABILITY FOR DEVICE TO COMPLETELY CLOSE-ALLOWING SAMPLES TO BE REMOVED" DURING A BIOPSY WHICH LED TO "BRIGHT RED BLEEDING".
Additional Manufacturer Narrative
ACCORDING TO THE CUSTOMER, ON (B)(6) 2025 DURING A "COLPOSCOPY" THERE WAS "POSSIBLE INABILITY FOR DEVICE TO COMPLETELY CLOSE-ALLOWING SAMPLES TO BE REMOVED" DURING A BIOPSY WHICH LED TO "BRIGHT RED BLEEDING". THE CUSTOMER REPORTED THE ESTIMATED BLOOD LOSS WAS GREATER THAN "125ML" AND THE PATIENT WAS REQUIRED TO BE "PUT UNDER GENERAL ANESTHESIA" FOR "REMOVAL OF BIOPSY TISSUE IN THE OR AND HEMOSTASIS OF BLEEDING COLPOSCOPY SITE". THE CUSTOMER REPORTED AS OF (B)(6) 2025 THE PATIENT WAS "DOING FINE". NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.