NOIR TRANSSPHENOIDAL SPECULA 90X13MM
Received Aug 9, 2018 · Event occurred Jul 10, 2018
Report 9610612-2018-00351 · MDR key 7770413
Device
Generic name
Instruments For Neurosurgery
Manufacturer
Aesculap AgModel number
FF590BCatalog number
FF590B
Lot number
52394914
Product problems
- Patient-Device Incompatibility
- Difficult to Open or Close
- Patient-Device Incompatibility
- Difficult to Open or Close
Patient
Not reported
- Nasal Obstruction
- Patient Problem/Medical Problem
- Nasal Obstruction
- Patient Problem/Medical Problem
Narrative
Additional Manufacturer Narrative
EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: THE DECONTAMINATED INSTRUMENTS ARE AVAILABLE FOR INVESTIGATION. THE OUTER THREADS OF THE SCREW HAVE BEEN EXAMINED AND FOUND TO BE ACCORDING TO THE SPECIFICATIONS AS WELL AS THE INNER THREADS OF THE LEGS OF THE INSTRUMENT. THE INSTRUMENT IS ACCORDING TO SPECIFICATIONS. THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS. THE DEVICE HISTORY FILE HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO OUR VALID SPECIFICATION AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THESE BATCHES. BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF THE INGESTION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT MAINTENANCE OF THE DEVICE. THE INSTRUMENTS OF THE COMPLAINT IS ACCORDING TO THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION.
Description of Event or Problem
COUNTRY OF COMPLAINT: (B)(6). DURING THE PROCEDURE, THERE WAS A TEMPORARY IMPAIRMENT OF THE NASAL MUCOSA. THE INSTRUMENT COULD NOT BE TURNED BACK TOGETHER INTRAOPERATIVELY. THE SCREW APPEARED TO BE DAMAGED AND WOULD NOT ALLOW THE INSTRUMENT TO OPEN AND CLOSE. THERE APPEARED TO BE TEMPORARY DAMAGE OF THE PATIENT'S NASAL MUCOSA THAT WILL HEAL FULLY AND WILL MOST LIKELY NOT NEGATIVELY INFLUENCE THE PATIENT IN THE FUTURE. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 9610612-2018-00350; 9610612-2018-00352; 9610612-2018-00353.
Additional Manufacturer Narrative
INVESTIGATION: THE INSTRUMENT IS IN GOOD CONDITION. NO DEVIATION CAN BE FOUND WITH THE NAKED EYE. THE OUTER THREADS OF THE SCREW HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATIONS AS WELL AS THE INNER THREADS OF THE LEGS OF THE INSTRUMENTS. THE INSTRUMENTS ARE ACCORDING TO SPECIFICATION. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS, AND FOUND TO BE ACCORDING TO SPECIFICATION VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE, AS WELL AS A RESULT OF OUR INVESTIGATION, THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT MAINTENANCE OF THE DEVICE. RATIONALE: THE INSTRUMENT ARE ACCORDING TO THE SPECIFICATION, VALID AT THE TIME OF PRODUCTION. NO CAPA IS NECESSARY.