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 2019-05-23 for ORCAPOD 4 SUV-629-50 2219-02 manufactured by Boston Scientific Corporation.
[145912162]
The complainant was unable to provide the event/procedure date, therefore the first day of the month in which the event was reported was used ((b)(6) 2019). The device was part of an orcapod 4 kit. The complainant was unable to provide the suspect device lot number for the kit; therefore, the expiration date, device manufacture dates are unknown. (b)(4). According to the complainant, the suspect device is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[145912163]
It was reported to boston scientific corporation that a seal biopsy valve was used in a colonoscopy procedure on an unknown date. According to the complainant, the seal biopsy valve squirted fluid out when the tech was cleaning the scope, post procedure. The procedure had been completed using this seal biopsy valve. There was no patient involved in this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-02658 |
| MDR Report Key | 8635619 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-23 |
| Date of Report | 2019-05-24 |
| Date of Event | 2019-04-01 |
| Date Mfgr Received | 2019-05-03 |
| Date Added to Maude | 2019-05-23 |
| 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 | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY , |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | POLYMER TECHNOLOGIES |
| Manufacturer Street | , |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORCAPOD 4 |
| Generic Name | ORCAPOD 4 |
| Product Code | ODC |
| Date Received | 2019-05-23 |
| Model Number | SUV-629-50 |
| Catalog Number | 2219-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY , MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-23 |