MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-19 for BIOSHIELD IRRIGATOR 00711133 manufactured by United States Endoscopy Group, Inc..
[39205497]
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 bioshield irrigator will also allow for remote irrigation via an attached irrigation line. Us endoscopy received a report from a (b)(4), that a bioshield leaked a lot of water. The leaking occurred during insufflation with an irrigation pump. The staff was wearing appropriate personal protective equipment (ppe). There was no reported harm to the patient or user. The device was not returned to for analysis. Review of the device history record (dhr) found no manufacturing or quality problems and all inspections were completed with acceptable results documented. The instructions for use (ifu) provides the following regarding leaks: 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. Example: 2. 3mm device in a 2. 8mm channel (space. 5mm) = inadequate space to allow for moderate pressure delivery of fluids; leakage may occur. Example: 2. 3mm device in a 3. 2mm channel (space. 9mm) = space is increased, keeping pressure in the moderate range, thus limiting the potential for valve connection leakage. For part #00711133 and #00711137: 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 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. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[39205498]
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 bioshield irrigator will also allow for remote irrigation via an attached irrigation line. Us endoscopy received a report from a distributor in (b)(4), that a bioshield leaked a lot of water. The leaking occurred during insufflation with an irrigation pump. The staff was wearing appropriate personal protective equipment (ppe). There was no reported harm to the patient or user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2016-00005 |
| MDR Report Key | 5448361 |
| Date Received | 2016-02-19 |
| Date of Report | 2016-02-19 |
| Date of Event | 2016-01-21 |
| Date Mfgr Received | 2016-01-22 |
| Device Manufacturer Date | 2015-11-08 |
| Date Added to Maude | 2016-02-19 |
| 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 | 2016-02-19 |
| Model Number | 00711133 |
| Catalog Number | 00711133 |
| Lot Number | 1518154 |
| Device Expiration Date | 2018-11-30 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-02-19 |