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 2018-05-24 for HYDRA SIT-576-15 manufactured by Boston Scientific - Marlborough.
[109193862]
The reported lot number could not be matched to the reported device. Therefore, the lot expiration and device manufacture dates are unknown at this time. (b)(4). Although the suspect device has been received, the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined. Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[109193863]
Note: this report pertains to one of two devices used during the same procedure. Refer to manufacturer report #: 3005099803-2018-01610 for the other associated device information. It was reported to boston scientific corporation that a hydra irrigation tubing was used in conjunction with a hydra olympus water jet connector during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2018. According to the complainant, after one procedure, a backflow into the tubing was noted during clean up. The patient's condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-01611 |
| MDR Report Key | 7542442 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-24 |
| Date of Report | 2018-05-03 |
| Date of Event | 2018-05-03 |
| Date Mfgr Received | 2018-07-18 |
| Date Added to Maude | 2018-05-24 |
| 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 | 2018-05-24 |
| Returned To Mfg | 2018-05-18 |
| Model Number | SIT-576-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-05-24 |