RUGGLES MICRO DISSECTOR - SPATULA - SMALL - 7 1/
Received Jul 1, 2025 · Event occurred Feb 10, 2025
Report 3014334038-2025-00090 · MDR key 22379165
Device
Product problems
- Nonstandard Device
- Product Quality Problem
- No Apparent Adverse Event
- Nonstandard Device
- Product Quality Problem
- No Apparent Adverse Event
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
UPDATED FIELDS: G3, G6, H2, H6/F10(MEDICAL DEVICE PROBLEM CODES), H11 ADDITIONAL INFORMATION FROM THE CUSTOMER RECEIVED ON 02-MAY-2025 INDICATED THAT THE SIZE WAS ACCEPTABLE. THIS ISSUE MAY BE THE RESULT OF USER PREFERENCE. THERE HAS BEEN NO RETURN OF PRODUCT FOR EVALUATION. THE DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.
Description of Event or Problem
N/A
Additional Manufacturer Narrative
THE RUGGLES MICRO DISSECTOR - SPATULA - SMALL -RN6206) WAS NOT RETURNED TO THE MANUFACTURER; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE ISSUE OF THE DEVICE BEING THE WRONG SIZE MAY BE THE RESULT OF CUSTOMER PREFERENCE FOR ANOTHER PRODUCT. IF RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.
Description of Event or Problem
IT WAS REPORTED THAT THE RUGGLES MICRO DISSECTOR - SPATULA - SMALL - 7 1/ (RN6206) WAS NOT AS SHARP AS EXPECTED, IT WAS BLUNT. THERE WAS NO PATIENT INJURY; HOWEVER, AN INCREASE IN SURGICAL TIME, GREATER THAN 30 MINUTES WAS REPORTED AS THEY HAD TO GET THE OLD SET FOR BOTH PRODUCTS. THE SURGERY WAS COMPLETED WITH ANOTHER PRODUCT AVAILABLE AT THE HOSPITAL.
Additional Manufacturer Narrative
UPDATED FIELDS: B5, G3, G6, H2, H6/F10 (MEDICAL DEVICE PROBLEM CODES).
Description of Event or Problem
IT WAS REPORTED THAT THE RUGGLES MICRO DISSECTOR - SPATULA - SMALL - 7 1/ (B)(6) WAS SMALLER THAN WHAT WAS PREVIOUSLY ORDERED BY THE HOSPITAL. THERE WAS NO PATIENT INJURY; HOWEVER, AN INCREASE IN SURGICAL TIME, GREATER THAN 30 MINUTES WAS REPORTED AS THEY HAD TO GET THE OLD SET FOR BOTH PRODUCTS. THE SURGERY WAS COMPLETED WITH ANOTHER PRODUCT AVAILABLE AT THE HOSPITAL.