MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-01 for BIOSHIELD BIOPSY VALVE 00711129 manufactured by United States Endoscopy Group, Inc..
[107215022]
The user facility subsequently reported that the tissue sample was in fact not lost, but had been retained within the biopsy valve. 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 biopsy valve lot number of the subject device was unknown by user facility personnel, and the biopsy valve was not returned for investigation. The forceps device used in the procedure was not identified; however, is not a product supplied by us endoscopy. A two-year review of complaint history shows no prior complaints of tissue loss for this the subject biopsy valve, nor for similar us endoscopy biopsy valves. Us endoscopy has not determined the biopsy valve malfunctioned, but rather is reporting due to our device being associated with the need for a follow-up patient procedure. Us endoscopy has offered in-service training; however, the user facility declined.
Patient Sequence No: 1, Text Type: N, H10
[107215023]
The user facility reported the loss of a tissue specimen when a forceps device was withdrawn through the bioshield biopsy valve. This required the patient return for a repeated procedure. There was no reported harm to the patient during the initial nor repeated procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2018-00012 |
| MDR Report Key | 7477124 |
| Date Received | 2018-05-01 |
| Date of Report | 2018-05-09 |
| Date Mfgr Received | 2018-05-02 |
| Date Added to Maude | 2018-05-01 |
| 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 | 2018-05-01 |
| Model Number | 00711129 |
| Catalog Number | 00711129 |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-05-01 |