MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-09 for RX LOCKING DEVICE AND BIOPSY CAP M00545260 manufactured by Boston Scientific Corporation.
[141341855]
Locking device and biopsy cap was placed on the biopsy channel of the ercp scope, per manufacturer guidelines, after the port of biopsy channel was dilated. The provider proceeded to feed the dreamtome through the port of the biopsy cap and met resistance. Upon removal of the scope, it was discovered the foam disc from the biopsy cap had dislodged and was pushed into the biopsy channel. No patient harm occurred. Per report from staff familiar with this device, this is not the first time this has happened. Device was retrieved but packaging was not. Similar in stock were lot#22804700. Manufacturer response for rx locking device and biopsy cap, olympus (per site reporter): unknown at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8495356 |
| MDR Report Key | 8495356 |
| Date Received | 2019-04-09 |
| Date of Report | 2019-03-29 |
| Date of Event | 2019-03-28 |
| Report Date | 2019-03-29 |
| Date Reported to FDA | 2019-03-29 |
| Date Reported to Mfgr | 2019-04-09 |
| Date Added to Maude | 2019-04-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Brand Name | RX LOCKING DEVICE AND BIOPSY CAP |
| Generic Name | ENDOSCOPE CHANNEL ACCESSORY |
| Product Code | ODC |
| Date Received | 2019-04-09 |
| Model Number | M00545260 |
| Lot Number | ?22804700 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-04-09 |