MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-12 for AW-500-G VERSION C 15932648 manufactured by Fuji Film Medical Systems.
[80678249]
When scope was removed from patient at the end of the procedure and physician went to suction enzymatic cleaner through the scope he noticed that the scope was continuously blowing air by itself. Patient underwent colonoscopy on (b)(6)2017. Upon completion of procedure when physician went to suction enzymatic solution through the scope he noticed that there was continuous air flow going through the scope even though he was not pressing the air/water button. Endoscope and buttons were cleaned and processed by means of high level disinfection and when tested for use for another procedure it was noticed that the scope still had a continuous air flow even though the air/water button was not being pressed. The buttons were changed with different buttons but the problem continued and the scope was taken out of service. Patient was admitted to hospital on (b)(6)2017 via the emergency department and underwent surgery for colonic perforation. Patient was discharged from the hospital on (b)(6)2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6727866 |
| MDR Report Key | 6727866 |
| Date Received | 2017-07-12 |
| Date of Report | 2017-07-11 |
| Date of Event | 2017-06-13 |
| Date Facility Aware | 2017-06-13 |
| Report Date | 2017-07-11 |
| Date Reported to FDA | 2017-07-11 |
| Date Reported to Mfgr | 2017-07-11 |
| Date Added to Maude | 2017-07-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AW-500-G VERSION C |
| Generic Name | AIR WATER BUTTON (VALVE) |
| Product Code | FFY |
| Date Received | 2017-07-12 |
| Returned To Mfg | 2017-06-27 |
| Catalog Number | 15932648 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FUJI FILM MEDICAL SYSTEMS |
| Manufacturer Address | WAYNE NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2017-07-12 |