MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-04-19 for HYDRA SIT-355-15 manufactured by Boston Scientific - Marlborough.
[106027629]
Patient? S exact age is unknown; however, it was reported that the patient was over the age of 18. The reported lot number could not be matched to the reported device. Therefore, the lot expiration and device manufacture dates are unknown. However, the complainant reported that the device was not expired. Mfg site name - endochoice. The complainant indicated that the device was disposed and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[106027630]
It was reported to boston scientific corporation that a hydra irrigation tubing was used during a colonoscopy procedure performed on (b)(6) 2017. According to the complainant, after a colonoscopy procedure, a yellow fluid was noted in the irrigation tubing in between the sterile water bottle and the scope. The backflow had not reached the sterile water bottle and was not noticed in the tubing between any other cases. Another hydra irrigation tubing was opened and used for the succeeding procedures. There were no patient complications at the conclusion of this procedure and the patient condition was noted to be? No injury.?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-01250 |
| MDR Report Key | 7442734 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-19 |
| Date of Report | 2017-09-08 |
| Date of Event | 2017-09-08 |
| Date Mfgr Received | 2017-09-08 |
| Date Added to Maude | 2018-04-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | EMP. NANCY CUTINO |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYDRA |
| Generic Name | PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE |
| Product Code | FEQ |
| Date Received | 2018-04-19 |
| Model Number | SIT-355-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-19 |