OLYMPUS TRACHEAL INTUBATION FIBERSCOPE
Report
- Report Number
- 8010047-2010-00110
- Event Type
- Other
- Date Received
- June 3, 2010
- Report Date
- May 5, 2010
- Manufacturer
- OLYMPUS MEDICAL SYSTEMS CORPORATION
- Product Code
- EOQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
OLYMPUS FOLLOWED UP WITH THE USER FACILITY REGARDING THIS REPORT. THE USERS REPORTED THE SAME BRONCHOSCOPE THAT WAS USED DURING THE BRONCHOSCOPY PROCEDURES WERE USED ON ALL SIX PATIENTS. THE BRONCHOSCOPE WAS REPORTED TO HAVE BEEN USED ON OTHER PATIENTS AROUND THE SAME TIME THE SIX PATIENTS UNDERWENT THE BRONCHOSCOPIES, BUT THESE OTHER PATIENTS HAD NOT TESTED POSITIVE. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL FOUND EVIDENCE OF RESIDUE AND DEBRIS INSIDE OF THE SUCTION PORT AND CHANNEL PIPE OF THE DEVICE. ADDITIONALLY, AN UNIDENTIFIED PURPLE STAIN WAS FOUND IN THE BIOPSY CHANNEL PROXIMAL TO THE BENDING SECTION AREA. THE DEVICE WAS FURTHER EXAMINED AND WAS FOUND TO BE LEAKING AT THE SUCTION CYLINDER UNIT AND CONTROL BODY BELOW THE PROTECTION BOOT. THE SUCTION CYLINDER WAS FOUND TO HAVE SCRAPE MARKS, THE INSERTION TUBE BOOT WAS FOUND BUCKLED BELOW THE PROTECTION BOOT, AND THE BIOPSY CHANNEL WAS NOTED TO BE KINKED. THE DEVICE WAS REFURBISHED. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS DISPATCHED TO VISIT THE USER FACILITY TO ASSESS THE REPROCESSING METHODS. DURING THE VISIT, THE ESS NOTED SEVERAL DEVIATIONS FROM THE REPROCESSING INSTRUCTIONS PROVIDED IN THE DEVICE INSTRUCTION MANUAL. THE ESS PROVIDED IN-SERVICE TRAINING ON THE APPROPRIATE REPROCESSING PROCEDURES WITH THE HOSPITAL STAFF. THE USER FACILITY INDICATED THEY HAVE RULED OUT THE BRONCHOSCOPE AS THE CAUSE OF THE PHENOMENON. THE EXACT CAUSE OF THE PHENOMENON COULD NOT BE DETERMINED, HOWEVER, INSUFFICIENT REPROCESSING CANNOT BE EXCLUDED AS A POTENTIALLY CONTRIBUTORY FACTOR. REFERENCE MFR REPORT NUMBER 8010047-2010-00111 FOR A RELATED REPORT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.
THE USER FACILITY REPORTED TO HAVE IDENTIFIED A CLUSTER OF SIX IN-PATIENTS THAT UNDERWENT BRONCHOSCOPIES AT THE USER FACILITY AND REPORTEDLY TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA. TWO OF THE SIX PATIENTS WERE REPORTED TO HAVE EXPIRED ON (B)(6) 2010, FOLLOWING THEIR PROCEDURES ON (B)(6) 2010, RESPECTIVELY. THE USER FACILITY REPORTED THAT THE TWO PATIENTS THAT EXPIRED LIKELY DID SO DUE TO UNDERLYING MEDICAL CONDITIONS. THE USER FACILITY FURTHER REPORTED THAT THE DEVICE WAS CULTURED TWICE AND TESTED NEGATIVE.
OLYMPUS FOLLOWED UP WITH THE USER FACILITY REGARDING THIS REPORT. THE USERS REPORTED THE SAME BRONCHOSCOPE THAT WAS USED DURING THE BRONCHOSCOPY PROCEDURES WERE USED ON ALL SIX PATIENTS. THE BRONCHOSCOPE WAS REPORTED TO HAVE BEEN USED ON OTHER PATIENTS AROUND THE SAME TIME THE SIX PATIENTS UNDERWENT THE BRONCHOSCOPIES, BUT THESE OTHER PATIENTS HAD NOT TESTED POSITIVE. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL FOUND EVIDENCE OF RESIDUE AND DEBRIS INSIDE OF THE SUCTION PORT AND CHANNEL PIPE OF THE DEVICE. ADDITIONALLY, AN UNIDENTIFIED PURPLE STAIN WAS FOUND IN THE BIOPSY CHANNEL PROXIMAL TO THE BENDING SECTION AREA. THE DEVICE WAS FURTHER EXAMINED AND WAS FOUND TO BE LEAKING AT THE SUCTION CYLINDER UNIT AND CONTROL BODY BELOW THE PROTECTION BOOT. THE SUCTION CYLINDER WAS FOUND TO HAVE SCRAPE MARKS, THE INSERTION TUBE BOOT WAS FOUND BUCKLED BELOW THE PROTECTION BOOT, AND THE BIOPSY CHANNEL WAS NOTED TO BE KINKED. THE DEVICE WAS REFURBISHED. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS DISPATCHED TO VISIT THE USER FACILITY TO ASSESS THE REPROCESSING METHODS. DURING THE VISIT, THE ESS NOTED SEVERAL DEVIATIONS FROM THE REPROCESSING INSTRUCTIONS PROVIDED IN THE DEVICE INSTRUCTION MANUAL. THE ESS PROVIDED IN-SERVICE TRAINING ON THE APPROPRIATE REPROCESSING PROCEDURES WITH THE HOSPITAL STAFF. THE USER FACILITY INDICATED THEY HAVE RULED OUT THE BRONCHOSCOPE AS THE CAUSE OF THE PHENOMENON. THE EXACT CAUSE OF THE PHENOMENON COULD NOT BE DETERMINED, HOWEVER, INSUFFICIENT REPROCESSING CANNOT BE EXCLUDED AS A POTENTIALLY CONTRIBUTORY FACTOR. REFERENCE MFR REPORT NUMBER 8010047-2010-00111 FOR A RELATED REPORT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.
THE USER FACILITY REPORTED TO HAVE IDENTIFIED A CLUSTER OF SIX IN-PATIENTS THAT UNDERWENT BRONCHOSCOPIES AT THE USER FACILITY AND REPORTEDLY TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA. TWO OF THE SIX PATIENTS WERE REPORTED TO HAVE EXPIRED ON (B)(6) 2010, FOLLOWING THEIR PROCEDURES ON (B)(6) 2010, RESPECTIVELY. THE USER FACILITY REPORTED THAT THE TWO PATIENTS THAT EXPIRED LIKELY DID SO DUE TO UNDERLYING MEDICAL CONDITIONS. THE USER FACILITY FURTHER REPORTED THAT THE DEVICE WAS CULTURED TWICE AND TESTED NEGATIVE.
OLYMPUS FOLLOWED UP WITH THE USER FACILITY REGARDING THIS REPORT. THE USERS REPORTED THE SAME BRONCHOSCOPE THAT WAS USED DURING THE BRONCHOSCOPY PROCEDURES WERE USED ON ALL SIX PATIENTS. THE BRONCHOSCOPE WAS REPORTED TO HAVE BEEN USED ON OTHER PATIENTS AROUND THE SAME TIME THE SIX PATIENTS UNDERWENT THE BRONCHOSCOPIES, BUT THESE OTHER PATIENTS HAD NOT TESTED POSITIVE. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL FOUND EVIDENCE OF RESIDUE AND DEBRIS INSIDE OF THE SUCTION PORT AND CHANNEL PIPE OF THE DEVICE. ADDITIONALLY, AN UNIDENTIFIED PURPLE STAIN WAS FOUND IN THE BIOPSY CHANNEL PROXIMAL TO THE BENDING SECTION AREA. THE DEVICE WAS FURTHER EXAMINED AND WAS FOUND TO BE LEAKING AT THE SUCTION CYLINDER UNIT AND CONTROL BODY BELOW THE PROTECTION BOOT. THE SUCTION CYLINDER WAS FOUND TO HAVE SCRAPE MARKS, THE INSERTION TUBE BOOT WAS FOUND BUCKLED BELOW THE PROTECTION BOOT, AND THE BIOPSY CHANNEL WAS NOTED TO BE KINKED. THE DEVICE WAS REFURBISHED. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS DISPATCHED TO VISIT THE USER FACILITY TO ASSESS THE REPROCESSING METHODS. DURING THE VISIT, THE ESS NOTED SEVERAL DEVIATIONS FROM THE REPROCESSING INSTRUCTIONS PROVIDED IN THE DEVICE INSTRUCTION MANUAL. THE ESS PROVIDED IN-SERVICE TRAINING ON THE APPROPRIATE REPROCESSING PROCEDURES WITH THE HOSPITAL STAFF. THE USER FACILITY INDICATED THEY HAVE RULED OUT THE BRONCHOSCOPE AS THE CAUSE OF THE PHENOMENON. THE EXACT CAUSE OF THE PHENOMENON COULD NOT BE DETERMINED, HOWEVER, INSUFFICIENT REPROCESSING CANNOT BE EXCLUDED AS A POTENTIALLY CONTRIBUTORY FACTOR. REFERENCE MFR REPORT NUMBER 8010047-2010-00111 FOR A RELATED REPORT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.
THE USER FACILITY REPORTED TO HAVE IDENTIFIED A CLUSTER OF SIX IN-PATIENTS THAT UNDERWENT BRONCHOSCOPIES AT THE USER FACILITY AND REPORTEDLY TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA. TWO OF THE SIX PATIENTS WERE REPORTED TO HAVE EXPIRED ON (B)(6) 2010, FOLLOWING THEIR PROCEDURES ON (B)(6) 2010, RESPECTIVELY. THE USER FACILITY REPORTED THAT THE TWO PATIENTS THAT EXPIRED LIKELY DID SO DUE TO UNDERLYING MEDICAL CONDITIONS. THE USER FACILITY FURTHER REPORTED THAT THE DEVICE WAS CULTURED TWICE AND TESTED NEGATIVE.
OLYMPUS FOLLOWED UP WITH THE USER FACILITY REGARDING THIS REPORT. THE USERS REPORTED THE SAME BRONCHOSCOPE THAT WAS USED DURING THE BRONCHOSCOPY PROCEDURES WERE USED ON ALL SIX PATIENTS. THE BRONCHOSCOPE WAS REPORTED TO HAVE BEEN USED ON OTHER PATIENTS AROUND THE SAME TIME THE SIX PATIENTS UNDERWENT THE BRONCHOSCOPIES, BUT THESE OTHER PATIENTS HAD NOT TESTED POSITIVE. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL FOUND EVIDENCE OF RESIDUE AND DEBRIS INSIDE OF THE SUCTION PORT AND CHANNEL PIPE OF THE DEVICE. ADDITIONALLY, AN UNIDENTIFIED PURPLE STAIN WAS FOUND IN THE BIOPSY CHANNEL PROXIMAL TO THE BENDING SECTION AREA. THE DEVICE WAS FURTHER EXAMINED AND WAS FOUND TO BE LEAKING AT THE SUCTION CYLINDER UNIT AND CONTROL BODY BELOW THE PROTECTION BOOT. THE SUCTION CYLINDER WAS FOUND TO HAVE SCRAPE MARKS, THE INSERTION TUBE BOOT WAS FOUND BUCKLED BELOW THE PROTECTION BOOT, AND THE BIOPSY CHANNEL WAS NOTED TO BE KINKED. THE DEVICE WAS REFURBISHED. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS DISPATCHED TO VISIT THE USER FACILITY TO ASSESS THE REPROCESSING METHODS. DURING THE VISIT, THE ESS NOTED SEVERAL DEVIATIONS FROM THE REPROCESSING INSTRUCTIONS PROVIDED IN THE DEVICE INSTRUCTION MANUAL. THE ESS PROVIDED IN-SERVICE TRAINING ON THE APPROPRIATE REPROCESSING PROCEDURES WITH THE HOSPITAL STAFF. THE USER FACILITY INDICATED THEY HAVE RULED OUT THE BRONCHOSCOPE AS THE CAUSE OF THE PHENOMENON. THE EXACT CAUSE OF THE PHENOMENON COULD NOT BE DETERMINED, HOWEVER, INSUFFICIENT REPROCESSING CANNOT BE EXCLUDED AS A POTENTIALLY CONTRIBUTORY FACTOR. REFERENCE MFR REPORT NUMBER 8010047-2010-00111 FOR A RELATED REPORT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.
THE USER FACILITY REPORTED TO HAVE IDENTIFIED A CLUSTER OF SIX IN-PATIENTS THAT UNDERWENT BRONCHOSCOPIES AT THE USER FACILITY AND REPORTEDLY TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA. TWO OF THE SIX PATIENTS WERE REPORTED TO HAVE EXPIRED ON (B)(6) 2010, FOLLOWING THEIR PROCEDURES ON (B)(6) 2010, RESPECTIVELY. THE USER FACILITY REPORTED THAT THE TWO PATIENTS THAT EXPIRED LIKELY DID SO DUE TO UNDERLYING MEDICAL CONDITIONS. THE USER FACILITY FURTHER REPORTED THAT THE DEVICE WAS CULTURED TWICE AND TESTED NEGATIVE.
OLYMPUS FOLLOWED UP WITH THE USER FACILITY REGARDING THIS REPORT. THE USERS REPORTED THE SAME BRONCHOSCOPE THAT WAS USED DURING THE BRONCHOSCOPY PROCEDURES WERE USED ON ALL SIX PATIENTS. THE BRONCHOSCOPE WAS REPORTED TO HAVE BEEN USED ON OTHER PATIENTS AROUND THE SAME TIME THE SIX PATIENTS UNDERWENT THE BRONCHOSCOPIES, BUT THESE OTHER PATIENTS HAD NOT TESTED POSITIVE. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL FOUND EVIDENCE OF RESIDUE AND DEBRIS INSIDE OF THE SUCTION PORT AND CHANNEL PIPE OF THE DEVICE. ADDITIONALLY, AN UNIDENTIFIED PURPLE STAIN WAS FOUND IN THE BIOPSY CHANNEL PROXIMAL TO THE BENDING SECTION AREA. THE DEVICE WAS FURTHER EXAMINED AND WAS FOUND TO BE LEAKING AT THE SUCTION CYLINDER UNIT AND CONTROL BODY BELOW THE PROTECTION BOOT. THE SUCTION CYLINDER WAS FOUND TO HAVE SCRAPE MARKS, THE INSERTION TUBE BOOT WAS FOUND BUCKLED BELOW THE PROTECTION BOOT, AND THE BIOPSY CHANNEL WAS NOTED TO BE KINKED. THE DEVICE WAS REFURBISHED. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS DISPATCHED TO VISIT THE USER FACILITY TO ASSESS THE REPROCESSING METHODS. DURING THE VISIT, THE ESS NOTED SEVERAL DEVIATIONS FROM THE REPROCESSING INSTRUCTIONS PROVIDED IN THE DEVICE INSTRUCTION MANUAL. THE ESS PROVIDED IN-SERVICE TRAINING ON THE APPROPRIATE REPROCESSING PROCEDURES WITH THE HOSPITAL STAFF. THE USER FACILITY INDICATED THEY HAVE RULED OUT THE BRONCHOSCOPE AS THE CAUSE OF THE PHENOMENON. THE EXACT CAUSE OF THE PHENOMENON COULD NOT BE DETERMINED, HOWEVER, INSUFFICIENT REPROCESSING CANNOT BE EXCLUDED AS A POTENTIALLY CONTRIBUTORY FACTOR. REFERENCE MFR REPORT NUMBER 8010047-2010-00111 FOR A RELATED REPORT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.
THE USER FACILITY REPORTED TO HAVE IDENTIFIED A CLUSTER OF SIX IN-PATIENTS THAT UNDERWENT BRONCHOSCOPIES AT THE USER FACILITY AND REPORTEDLY TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA. TWO OF THE SIX PATIENTS WERE REPORTED TO HAVE EXPIRED ON (B)(6) 2010, FOLLOWING THEIR PROCEDURES ON (B)(6) 2010, RESPECTIVELY. THE USER FACILITY REPORTED THAT THE TWO PATIENTS THAT EXPIRED LIKELY DID SO DUE TO UNDERLYING MEDICAL CONDITIONS. THE USER FACILITY FURTHER REPORTED THAT THE DEVICE WAS CULTURED TWICE AND TESTED NEGATIVE.
OLYMPUS FOLLOWED UP WITH THE USER FACILITY REGARDING THIS REPORT. THE USERS REPORTED THE SAME BRONCHOSCOPE THAT WAS USED DURING THE BRONCHOSCOPY PROCEDURES WERE USED ON ALL SIX PATIENTS. THE BRONCHOSCOPE WAS REPORTED TO HAVE BEEN USED ON OTHER PATIENTS AROUND THE SAME TIME THE SIX PATIENTS UNDERWENT THE BRONCHOSCOPIES, BUT THESE OTHER PATIENTS HAD NOT TESTED POSITIVE. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL FOUND EVIDENCE OF RESIDUE AND DEBRIS INSIDE OF THE SUCTION PORT AND CHANNEL PIPE OF THE DEVICE. ADDITIONALLY, AN UNIDENTIFIED PURPLE STAIN WAS FOUND IN THE BIOPSY CHANNEL PROXIMAL TO THE BENDING SECTION AREA. THE DEVICE WAS FURTHER EXAMINED AND WAS FOUND TO BE LEAKING AT THE SUCTION CYLINDER UNIT AND CONTROL BODY BELOW THE PROTECTION BOOT. THE SUCTION CYLINDER WAS FOUND TO HAVE SCRAPE MARKS, THE INSERTION TUBE BOOT WAS FOUND BUCKLED BELOW THE PROTECTION BOOT, AND THE BIOPSY CHANNEL WAS NOTED TO BE KINKED. THE DEVICE WAS REFURBISHED. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS DISPATCHED TO VISIT THE USER FACILITY TO ASSESS THE REPROCESSING METHODS. DURING THE VISIT, THE ESS NOTED SEVERAL DEVIATIONS FROM THE REPROCESSING INSTRUCTIONS PROVIDED IN THE DEVICE INSTRUCTION MANUAL. THE ESS PROVIDED IN-SERVICE TRAINING ON THE APPROPRIATE REPROCESSING PROCEDURES WITH THE HOSPITAL STAFF. THE USER FACILITY INDICATED THEY HAVE RULED OUT THE BRONCHOSCOPE AS THE CAUSE OF THE PHENOMENON. THE EXACT CAUSE OF THE PHENOMENON COULD NOT BE DETERMINED, HOWEVER, INSUFFICIENT REPROCESSING CANNOT BE EXCLUDED AS A POTENTIALLY CONTRIBUTORY FACTOR. REFERENCE MFR REPORT NUMBER 8010047-2010-00111 FOR A RELATED REPORT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.
THE USER FACILITY REPORTED TO HAVE IDENTIFIED A CLUSTER OF SIX IN-PATIENTS THAT UNDERWENT BRONCHOSCOPIES AT THE USER FACILITY AND REPORTEDLY TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA. TWO OF THE SIX PATIENTS WERE REPORTED TO HAVE EXPIRED ON (B)(6) 2010, FOLLOWING THEIR PROCEDURES ON (B)(6) 2010, RESPECTIVELY. THE USER FACILITY REPORTED THAT THE TWO PATIENTS THAT EXPIRED LIKELY DID SO DUE TO UNDERLYING MEDICAL CONDITIONS. THE USER FACILITY FURTHER REPORTED THAT THE DEVICE WAS CULTURED TWICE AND TESTED NEGATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OLYMPUS TRACHEAL INTUBATION FIBERSCOPE | TRACHEAL INTUBATION FIBERSCOPE | EOQ | OLYMPUS MEDICAL SYSTEMS CORPORATION | LF-TP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | DEVICE: MODEL UNKNOWN| CUSTOM ULTRASONICS AUTOMATIC ENDOSCOPE REPROCESSOR| SERIAL NUMBER: UNKNOWN | ||
| 2 | 47 YR | SERIAL NUMBER: UNKNOWN| DEVICE: MODEL UNKNOWN| CUSTOM ULTRASONICS AUTOMATIC ENDOSCOPE REPROCESSOR | ||
| 3 | 68 YR | DEVICE: MODEL UNKNOWN| CUSTOM ULTRASONICS AUTOMATIC ENDOSCOPE REPROCESSOR| SERIAL NUMBER: UNKNOWN | ||
| 4 | 67 YR | CUSTOM ULTRASONICS AUTOMATIC ENDOSCOPE REPROCESSOR| SERIAL NUMBER: UNKNOWN| DEVICE: MODEL UNKNOWN | ||
| 5 | 69 YR | CUSTOM ULTRASONICS AUTOMATIC ENDOSCOPE REPROCESSOR| SERIAL NUMBER: UNKNOWN| DEVICE: MODEL UNKNOWN | ||
| 6 | 46 YR | DEVICE: MODEL UNKNOWN| CUSTOM ULTRASONICS AUTOMATIC ENDOSCOPE REPROCESSOR| SERIAL NUMBER: UNKNOWN |