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 2018-12-26 for RX LOCKING DEVICE AND BIOPSY CAP M00545260 4526S manufactured by Boston Scientific Corporation.
[131478019]
The exact date of the event is unknown. The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[131478020]
It was reported to boston scientific corporation that an rx locking device biopsy cap was used on an unknown date. The complainant reported that during the procedure, the sponge became dislodged and got stuck in the working channel of the scope, blocking all devices from being able to pass through the scope. The procedure was completed using another endoscope. There was no serious injury nor adverse patient effects reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-62256 |
| MDR Report Key | 8197521 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-26 |
| Date of Report | 2019-02-26 |
| Date of Event | 2018-12-01 |
| Date Mfgr Received | 2019-02-06 |
| Device Manufacturer Date | 2018-10-02 |
| Date Added to Maude | 2018-12-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CAROLE MORLEY |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY , |
| Manufacturer City | MARLBOROUGH MA 017521242 |
| Manufacturer Country | US |
| Manufacturer Postal | 017521242 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 780 BROOKSIDE DRIVE , |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RX LOCKING DEVICE AND BIOPSY CAP |
| Generic Name | ENDOSCOPE AND/OR ACCESSORIES |
| Product Code | ODC |
| Date Received | 2018-12-26 |
| Returned To Mfg | 2019-01-11 |
| Model Number | M00545260 |
| Catalog Number | 4526S |
| Lot Number | 0022734284 |
| 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 CORPORATION |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY , MARLBOROUGH MA 017521242 US 017521242 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-26 |