DISP BIOPSY PUNCHES 4MM
Received Sep 16, 2025 · Event occurred Aug 28, 2025
Report 3014334038-2025-00128 · MDR key 23062643
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
24 YR · Female
- Abrasion
- Abrasion
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
A FACILITY REPORTED THAT WHILE SETTING UP THE DISP BIOPSY PUNCHES 4MM (33-34), FOR A PUNCH BIOPSY, ONE OF THE STAFF WAS STRUGGLING TO OPEN THE PUNCH BIOPSY TOOL. WHILE ATTEMPTING TO OPEN THE TOOL, IT BROKE THROUGH THE PLASTIC AND SCRAPED HER PALM, PIERCING THE GLOVES SHE WAS WEARING AND HER SKIN AS WELL. AN ABRASION/CUT TO THE STAFF'S PALM WAS REPORTED, AND THE EMPLOYEE WAS SEEN BY THE EMPLOYEE HEALTH; NO FURTHER MEDICAL TREATMENT WAS NEEDED. THERE WAS NO PATIENT INVOLVEMENT, THUS NO INJURY, DEATH OR SURGICAL DELAY REPORTED.
Additional Manufacturer Narrative
UPDATED FIELDS: D9, G3, G6, H2, H11. ADDITIONAL INFORMATION: H6 (TYPE OF INVESTIGATION), AND ROOT CAUSE ANALYSIS. ROOT CAUSE ANALYSIS: THERE HAS BEEN NO RETURN OF PRODUCT FOR EVALUATION. INVESTIGATION BY THE PRODUCT SUPPLIER COULD NOT IDENTIFY ANY MANUFACTURING ERROR OR ANOMALIES WITH RETAINED SAMPLES OR PRODUCTION RECORDS. THE DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.
Description of Event or Problem
N/A.
Description of Event or Problem
N/A.
Additional Manufacturer Narrative
UPDATED FIELDS: D9, G3, G6, H2, H3, H6, H11. CORRECTED FIELDS: B1 ADVERSE EVENT/PRODUCT PROBLEM: CHANGED TO PRODUCT PROBLEM. H1: CHANGED FROM SERIOUS INJURY TO MALFUNCTION. THE DISP BIOPSY PUNCHES 4MM (90622) WAS NOT RETURNED TO THE MANUFACTURER AFTER THREE GOOD FAITH EFFORT (GFE) ATTEMPTS TO RETRIEVE THE PRODUCT. DEVICE HISTORY RECORD (DHR): THE MANUFACTURER'S REVIEW OF THE DHR FOUND NO ABNORMALITIES THAT COULD CONTRIBUTE TO THE REPORTED ISSUE. THE DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE ISSUE OF BREAKING OUT OF THE PLASTIC MAY BE THE RESULT OF THE USER PUSHING IT OUT THROUGH THE CUTTING END RATHER THAN THE INDICATED HANDLE END. THE CUSTOMER DESCRIBED PUSHING THE PUNCH OUT OF THE CUTTING END RATHER THAN THE INDICATED HANDLE END. THE SUPPLIER REVIEW OF THE COMPLAINT IS ONGOING. THIS COMPLAINT MAY BE UPDATED WITH ADDITIONAL FINDINGS FROM THE SUPPLIER.