MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-24 for BIOSHIELD BIOPSY VALVE 00711126 manufactured by United States Endoscopy Group, Inc..
[83639849]
Review of the device history record indicates no issues during manufacture; the device was manufactured to specification. The subject device was not returned to us endoscopy. The instructions for use contain the following warnings and precautions: "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. Do not leave a device hanging from the valve. Doing so can cause the creation of a larger valve slit/hole that may cause leakage. 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. " in-service training has been provided to the user. Follow up has confirmed no additional issues. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[83639850]
The biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a gastrointestinal endoscope. The biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the gastrointestinal endoscopic procedure. The user facility reported during a procedure the lid of the biopsy valve opened and sprayed a nurse with bodily fluid. The nurse was wearing proper personal protective equipment however the fluid came in contact with her skin. The nurse washed the affected skin and no further treatment was sought. There was no report of harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2017-00024 |
| MDR Report Key | 6817396 |
| Date Received | 2017-08-24 |
| Date of Report | 2017-08-24 |
| Date of Event | 2017-07-28 |
| Date Mfgr Received | 2017-07-28 |
| Device Manufacturer Date | 2017-06-02 |
| Date Added to Maude | 2017-08-24 |
| 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 BIOPSY VALVE |
| Generic Name | BIOPSY VALVE |
| Product Code | ODD |
| Date Received | 2017-08-24 |
| Model Number | 00711126 |
| Catalog Number | 00711126 |
| Lot Number | 1709435 |
| Operator | PHYSICIAN |
| 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 | 1. Other | 2017-08-24 |