MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-27 for BIOSHIELD BIOPSY VALVE 00711124 manufactured by United States Endoscopy Group, Inc..
[118554773]
The bioshield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a gastrointestinal endoscope. The bioshield 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 device history record was reviewed and confirmed the devices were manufactured to specification. There have been no other complaints associated with this lot. The devices subject of this complaint were not returned to us endoscopy for evaluation. The instructions for use include the following statements: "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. "
Patient Sequence No: 1, Text Type: N, H10
[118554774]
The distributor in the (b)(4) received report of bodily fluid spray during passage of devices through bioshield biopsy valves. There was no report of patient or user contact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2018-00025 |
| MDR Report Key | 7820450 |
| Date Received | 2018-08-27 |
| Date of Report | 2018-08-27 |
| Date Mfgr Received | 2018-07-30 |
| Device Manufacturer Date | 2018-02-28 |
| Date Added to Maude | 2018-08-27 |
| 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 | 2018-08-27 |
| Model Number | 00711124 |
| Catalog Number | 00711124 |
| Lot Number | 1803293 |
| 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 | 2018-08-27 |