NOIR TRANSSPHENOIDAL SPECULA 90X13MM
Received Aug 9, 2018 · Event occurred Jul 10, 2018
Report 9610612-2018-00353 · MDR key 7770412
Device
Generic name
Instruments For Neurosurgery
Manufacturer
Aesculap AgModel number
FF590BCatalog number
FF590B
Lot number
52284292
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. A FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO BROKEN THREADS ON THE DEVICE. THE SCREW COULD NOT BE REMOVED FROM THE LEG OF THE INSTRUMENT. THE INNER THREAD OF THE OTHER LEG OF THE DEVICE IS NOT WITHIN SPECIFICATION. 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 INSTRUMENT OF THIS COMPLAINT IS MOST LIKELY BROKEN DUE TO AN INSUFFICIENT LUBRICATION DURING THE REPROCESSING.
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; 9610612-2018-00351; 9610612-2018-00352.
Additional Manufacturer Narrative
INVESTIGATION: THE INSTRUMENT IS IN GOOD CONDITION, HOWEVER, A FUNCTIONAL TEST COULD NOT BE CARRIED OUT DUE TO BROKEN THREADS. THE SEIZED UP SCREW COULD NOT BE REMOVED FROM THE LEG OF THE INSTRUMENT. THE INNER THREAD OF THE OTHER LEG IS TRUE TO GAUGE. 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 ID MOST LIKELY BROKEN DUE TO AN INSUFFICIENT LUBRICATION DURING THE REPROCESSING PROCESS. NO CAPA IS NECESSARY.