MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-24 for BIOSHIELD IRRIGATOR 00711133 manufactured by United States Endoscopy Group, Inc..
[146339282]
The user facility reported that no devices had been passed through the biopsy port of the bioshield prior to the reported events. The devices subject of the reported event were not returned; however, the distributor returned several unused devices from the same lot. Examination and dimensional checks of the returned devices found them to be within specifications. The device history record was reviewed and confirmed the device was manufactured to specification. There have been no other complaints associated with this lot. The instructions for use include the following statements: "exposure to bodily fluids may occur during connection or disconnection of these devices; adherence to body substance isolation protocols is the responsibility of the user. If the lid of the valve is opened while attached to the endoscope during a procedure, scope suction will be compromised and leakage may occur. If leakage occurs, a sterile gauze should be used to cover the valve. " the distributor provided in-service training to the customer and attempted to recreate the reported event with the customer without success. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[146339283]
The distributor reported multiple instances of the cap of the bioshield irrigator opening during procedures, resulting in liquid being projected from the biopsy port. No harm to patients or users was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2019-00022 |
| MDR Report Key | 8641706 |
| Date Received | 2019-05-24 |
| Date of Report | 2019-05-24 |
| Date of Event | 2019-04-24 |
| Date Mfgr Received | 2019-04-25 |
| Device Manufacturer Date | 2018-11-30 |
| Date Added to Maude | 2019-05-24 |
| 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 | MRS. COLETTA COHARA |
| Manufacturer Street | 5976 HEISLEY RD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403586251 |
| Manufacturer G1 | UNITED STATES ENDOSCOPY GROUP, INC. |
| Manufacturer Street | 5976 HEISLEY RD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BIOSHIELD IRRIGATOR |
| Generic Name | BIOPSY VALVE |
| Product Code | ODD |
| Date Received | 2019-05-24 |
| Model Number | 00711133 |
| Catalog Number | 00711133 |
| Lot Number | 1819735 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNITED STATES ENDOSCOPY GROUP, INC. |
| Manufacturer Address | 5976 HEISLEY RD MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-24 |