MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-04 for BIOSHIELD IRRIGATOR 00711133 manufactured by United States Endoscopy Group, Inc..
[57054986]
The bioshield irrigator biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a gastrointestinal endoscope. The bioshield irrigator 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 bioshield irrigator will also allow for remote irrigation via an attached irrigation line. Us endoscopy received a report regarding a bioshield irrigator biopsy valve. The report indicated that the bioshield irrigator biopsy valve sprayed fluid during the procedure. The staff wore appropriate ppe and did not come into direct contact with the leaked fluid. There was no harm to the patient or user as a result of the leaking. The device history record (dhr) was reviewed and indicated that all in-process and final inspections were performed and acceptable results were documented. The actual device was not returned for evaluation. Information included in the instructions for use includes: "irrigating through the bioshield biopsy valve's irrigation line with a device in the biopsy channel requires sufficient space between the diameter of the device and the diameter of the endoscope's channel. Adequate space is required to allow fluid to pass freely at a moderate pressure so that the valve connections do not leak. Leakage through non-sheathed spring-coiled devices such as biopsy forceps will occur if irrigation is performed while the non-sheathed device remains in the biopsy channel. Do not leave a device hanging from the valve. Doing so can cause the creation of a lager valve slit/hole that may cause leakage. If leakage occurs, a sterile gauze should be used to cover the valve. " if additional information because available this report will be updated. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[57054987]
The bioshield irrigator biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a gastrointestinal endoscope. The bioshield irrigator 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 bioshield irrigator will also allow for remote irrigation via an attached irrigation line. Us endoscopy received a report regarding a bioshield irrigator biopsy valve. The report indicated that the bioshield irrigator biopsy valve sprayed fluid during the procedure. The staff wore appropriate ppe and did not come into direct contact with the leaked fluid. There was no harm to the patient or user as a result of the leaking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2016-00025 |
| MDR Report Key | 5998024 |
| Date Received | 2016-10-04 |
| Date of Report | 2016-10-04 |
| Device Manufacturer Date | 2016-03-14 |
| Date Added to Maude | 2016-10-04 |
| 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 ROAD |
| 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 | 2016-10-04 |
| Model Number | 00711133 |
| Catalog Number | 00711133 |
| Lot Number | 1602988 |
| Device Expiration Date | 2019-03-31 |
| 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 | 2016-10-04 |