PENTAX
Report
- Report Number
- 9610877-2016-00172
- Event Type
- Injury
- Date Received
- October 6, 2016
- Report Date
- September 6, 2016
- Manufacturer
- HOYA CORPORATION PENTAX TOKYO OFFICE
- Product Code
- EOQ
- PMA / PMN Number
- K951199
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
(B)(4). MDR 9610877-2016-00162 INCLUDES INFORMATION ON THE FIRST PATIENT AND PENTAX MODEL FB-10V/SERIAL (B)(4). MDR 9610877-2016-00163 INCLUDES INFORMATION ON THE SECOND PATIENT AND PENTAX MODEL FB-18BS/SERIAL (B)(4). MDR 9610877-2016-00164 INCLUDES INFORMATION ON THE THIRD PATIENT WITH UNSPECIFIED SCOPE. MDR 9610877-2016-00165 INCLUDES INFORMATION ON THE FOURTH PATIENT WITH UNSPECIFIED SCOPE. MDR 9610877-2016-00166 INCLUDES INFORMATION ON THE FIFTH PATIENT WITH UNSPECIFIED SCOPE. MDR 9610877-2016-00167 INCLUDES INFORMATION ON THE SIXTH PATIENT WITH UNSPECIFIED SCOPE. MDR 9610877-2016-00168 INCLUDES INFORMATION ON THE SEVENTH PATIENT WITH UNSPECIFIED SCOPE. MDR 9610877-2016-00169 INCLUDES INFORMATION ON THE EIGHTH PATIENT WITH UNSPECIFIED SCOPE. MDR 9610877-2016-00170 INCLUDES INFORMATION ON THE NINTH PATIENT WITH UNSPECIFIED SCOPE. MDR 9610877-2016-00171 INCLUDES INFORMATION ON THE TENTH PATIENT WITH UNSPECIFIED SCOPE. MDR 9610877-2016-00172 INCLUDES INFORMATION ON THE ELEVENTH PATIENT WITH UNSPECIFIED SCOPE. MDR 9610877-2016-00173 INCLUDES INFORMATION ON THE TWELFTH PATIENT WITH UNSPECIFIED SCOPE. MDR 9610877-2016-00174 INCLUDES INFORMATION ON THE THIRTEENTH PATIENT WITH UNSPECIFIED SCOPE. THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED TO PENTAX MEDICAL FOR EVALUATION. (EXEMPTION NUMBER E2015036).
(B)(4). MDR 9610877-2016-00162 INCLUDES INFORMATION ON THE FIRST PATIENT AND PENTAX MODEL FB-10V/SERIAL (B)(4). MDR 9610877-2016-00163 INCLUDES INFORMATION ON THE SECOND PATIENT AND PENTAX MODEL FB-18BS/SERIAL (B)(4). MDR 9610877-2016-00164 INCLUDES INFORMATION ON THE THIRD PATIENT WITH UNSPECIFIED SCOPE. MDR 9610877-2016-00165 INCLUDES INFORMATION ON THE FOURTH PATIENT WITH UNSPECIFIED SCOPE. MDR 9610877-2016-00166 INCLUDES INFORMATION ON THE FIFTH PATIENT WITH UNSPECIFIED SCOPE. MDR 9610877-2016-00167 INCLUDES INFORMATION ON THE SIXTH PATIENT WITH UNSPECIFIED SCOPE. MDR 9610877-2016-00168 INCLUDES INFORMATION ON THE SEVENTH PATIENT WITH UNSPECIFIED SCOPE. MDR 9610877-2016-00169 INCLUDES INFORMATION ON THE EIGHTH PATIENT WITH UNSPECIFIED SCOPE. MDR 9610877-2016-00170 INCLUDES INFORMATION ON THE NINTH PATIENT WITH UNSPECIFIED SCOPE. MDR 9610877-2016-00171 INCLUDES INFORMATION ON THE TENTH PATIENT WITH UNSPECIFIED SCOPE. MDR 9610877-2016-00172 INCLUDES INFORMATION ON THE ELEVENTH PATIENT WITH UNSPECIFIED SCOPE. MDR 9610877-2016-00173 INCLUDES INFORMATION ON THE TWELFTH PATIENT WITH UNSPECIFIED SCOPE. MDR 9610877-2016-00174 INCLUDES INFORMATION ON THE THIRTEENTH PATIENT WITH UNSPECIFIED SCOPE. (EXEMPTION NUMBER E2015036).
(B)(4). (EXEMPTION NUMBER E2015036).
PENTAX MEDICAL WAS MADE AWARE OF A REPORT FOR EVENTS WHICH OCCURRED IN THE (B)(6) STATING "13 OUTBREAKS OF STENOTROPHOMONAS MALTOPHILIA". THE REPORT ALSO STATED THESE EVENTS INVOLVED "PROCEDURES USING OUR BRONCHOSCOPES" (PENTAX MODEL FB-10V/SERIAL (B)(4) AND PENTAX MODEL FB-18BS/SERIAL (B)(4)). THE FIBER BRONCHOSCOPES WERE SENT TO A THIRD PARTY COMPANY FOR TESTING. NO RESULTS HAVE BEEN RECEIVED TO DATE. THE DEVICES ARE CURRENTLY QUARANTINED AT THE FACILITY. PENTAX MEDICAL SENT MULTIPLE GOOD FAITH EFFORT COMMUNICATIONS TO THE FACILITY (I.E. 09/07/2016, 09/09/2016, 09/12/2016, 09/14/2016, 09/16/2016, 09/19/2016, 09/20/2016 AND 09/30/2016) IN ORDER TO OBTAIN CLARIFICATION AS TO WHETHER THERE WERE 13 INCIDENTS IN TOTAL AMONG THE TWO IDENTIFIED SCOPES, OR 13 FOR EACH SCOPE, AS WELL AS ADDITIONAL INFORMATION CONFIRMING THE MODEL/SERIAL NUMBER OF THE FIBER BRONCHOSCOPE USED ON EACH PATIENT. ADDITIONAL INFORMATION RECEIVED FROM THE FACILITY INDICATED THAT THERE HAS BEEN A TOTAL OF 16 CASES OF STENOTROPHOMONAS MALTOPHILIA- 13 INVOLVED PATIENTS WHO UNDERWENT PROCEDURES WITH ONE OF THE TWO IDENTIFIED PENTAX SCOPES AND AN ADDITIONAL THREE PATIENTS WHO DID NOT UNDERGO PROCEDURES WITH A PENTAX MEDICAL DEVICE. THE FACILITY STATED POSSIBLE SOURCES OF THE INFECTIONS MAY BE THE WATER SUPPLY, THE STORAGE CABINETS THAT HOLD WATER IN THE SCOPES FOR PROLONGED PERIODS OF TIME OR POTENTIALLY THE SCOPES. THE FACILITY ALSO STATED THE BRONCHOSCOPES WERE LAST REPROCESSED ON 08/24/2016. NO FURTHER INFORMATION ON THE PATIENTS OR THE DEVICES HAS BEEN RECEIVED TO DATE. THIRTEEN SEPARATE MDRS ARE BEING FILED TO REFLECT THE 13 INCIDENTS REPORTED. PENTAX EUROPE (B)(4) SUBMITTED A MANUFACTURER'S INCIDENT REPORT TO (B)(6) ON 10/06/2016.
PENTAX EUROPE (B)(4) SUBMITTED A MANUFACTURER'S INCIDENT REPORT TO (B)(6) ON (B)(6) 2016. THE REPORT STATED THE FOLLOWING: "OUR INVESTIGATION REVEALED THE DEVICES WERE IN NON-OPERATIONAL CONDITION UPON ARRIVAL AT OUR FACILITIES, E.G. MECHANICAL DAMAGES, AND BIOFILMS WERE OBSERVED. A MICROBIOLOGICAL ASSESSMENT BY AN ACCREDITED LABORATORY IN (B)(6) PRIOR TO REPROCESSING AT OUR FACILITIES REVEALED THE FOLLOWING RESULTS: ON THE DEVICE PENTAX FB-10V (SER.NO. (B)(4)) THE FOLLOWING MIRCOORGANISMS WERE DETECTED: MICROCOCCUS LUTEUS, MEYEROZYMA GUILLIERMONDII, (B)(6)., MUCOR SPP . , RHIZOPUS SPP. GROWTH IN THE ENRICHMENT CULTURE: MEYEROZYMA GUILLIERMONDII. ON THE DEVICE PENTAX FB-18BS (SER.NO. (B)(4)) THE FOLLOWING MICROORGANISMS WERE DETECTED: MICROCOCCUS LUTEUS, STENOTROPHOMONAS MALTOPHILIA, MUCOR SPP., RHIZOPUS SPP. GROWTH IN THE ENRICHMENT CULTURE: STENOTROPHOMONAS MALTOPHILIA. EVEN THOUGH THE DEVICES ARE IN POOR CONDITION, WE WERE ABLE TO REPROCESS BOTH OF THE DEVICES SUCCESSFULLY AS PER THE IFU AT OUR FACILITIES. AT ONE OF THE DEVICES (FB-10V, SER.NO. (B)(4)) THERE WERE STILL MICROORGANISMS (MIKROCOCCI, AEROBIC SPORE-FORMING BACTERIA, MORAXELLA OSLOENSIS, ULCOLADIUM SPP.) DETECTED AFTER REPROCESSING. THIS DEVICE DID SHOW THE MOST CRITICAL MECHANICAL DAMAGE: THE INSTRUMENTATION CHANNEL DOES SHOW A SHARP KINK. HOWEVER, THE RESULTS WERE UNCRITICAL FROM AN INFECTION CONTROL POINT OF VIEW. EVIDENCE (RESULTS FROM THE LABORATORY) CAN BE PROVIDED UPON REQUEST. FURTHER RESULTS OF THE MICROBIOLOGICAL ASSESSMENT CARRIED OUT BY ANOTHER LABORATORY IN THE (B)(6) ((B)(6)) ON OTHER EQUIPMENT OF THE HOSPITAL (WATER PURIFICATION SYSTEM ETC.) WERE NOT DISCLOSED TO PENTAX, THUS WE ARE UNABLE TO IDENTIFY THE SOURCE OF THE INFECTION WITH STENOTROPHOMONAS MALTOPHILIA. THE IFU OF ALL PENTAX ENDOSCOPES DO REQUEST THE USERS TO CHECK THE DEVICES CAREFULLY PRIOR TO AND AFTER USE IN ORDER TO IDENTIFY ANY DAMAGES ETC. THAT MAY HAVE AN IMPACT ON THE SAFES USE. WE WILL STRONGLY RECOMMEND A MAJOR REPAIR FOR BOTH DEVICES PRIOR TO ANY FURTHER USE AND WILL COMMUNICATE THIS WITH THE USER ACCORDINGLY."
ON 26-OCT-2016, A DEVICE HISTORY REVIEW WAS PERFORMED CONFIRMING PENTAX MODEL FB-10V/SERIAL (B)(4) WAS MANUFACTURED UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED. APPROXIMATE AGE OF DEVICE: 13 YEARS. ON 02-NOV-2016, A DEVICE HISTORY REVIEW WAS PERFORMED CONFIRMING PENTAX MODEL FB-18BS/SERIAL (B)(4) WAS MANUFACTURED UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED. APPROXIMATE AGE OF DEVICE: 17 YEARS. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE CONSIDERS THIS MEDWATCH REPORT CLOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 658200 | PENTAX | FIBER BRONCHOSCOPE | EOQ | HOYA CORPORATION PENTAX TOKYO OFFICE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |