MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-13 for BIOGUARD AIR/WATER & SUCTION VALVES KIT 00711784 manufactured by United States Endoscopy Group, Inc..
[137832510]
The valve is included within the bioguard air/water and suction kit. The 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 and provides access for irrigation. The device subject of the reported event was discarded by the user facility. 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 the valve". The device history record was reviewed and confirmed the device was manufactured to specification. There have been no other complaints associated with this lot. Us endoscopy has provided in-service training to the user facility, and no further issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[137832511]
The user facility reported the lid of the biopsy valve opened, with resultant fluid spray from the device during procedural use. The fluid did not contact the user, and there was no report of harm to the patient or user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2019-00011 |
| MDR Report Key | 8337355 |
| Date Received | 2019-02-13 |
| Date of Report | 2019-02-13 |
| Date Mfgr Received | 2019-01-14 |
| Date Added to Maude | 2019-02-13 |
| 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 | BIOGUARD AIR/WATER & SUCTION VALVES KIT |
| Generic Name | BIOPSY VALVE |
| Product Code | ODC |
| Date Received | 2019-02-13 |
| Model Number | 00711784 |
| Catalog Number | 00711784 |
| Lot Number | 1808083 |
| 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 | 2019-02-13 |