MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-06 for GUARDUS OVERTUBE - GASTRIC 00711148 manufactured by United States Endoscopy Group, Inc..
[119655688]
The disposable overtube is a device used in conjunction with a flexible endoscope for foreign body or tissue retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations. The report indicates that the tip of the overtube detached during a procedure. The detachment was noted after the procedure was completed and the detached component was retrieved. 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 device subject of this complaint was not returned to us endoscopy for evaluation. The instructions for use include the following statements: "inspect the package for shipping or handling damage (i. E. Deformed tubes, holes in packaging). If damage is evident, do not use this device. Generously lubricate both components with a water soluble lubricant as described below in the directions for use. Do not assemble without generous lubrication. " the distributor has provided in-service training to the facility. There have been no further reported issues since in-service was completed.
Patient Sequence No: 1, Text Type: N, H10
[119655909]
The distributor in (b)(4) reported the tip detached from a guardus overtube during procedural use. The detached portion was retrieved, and the procedure was completed. There was no report of patient or user harm as a result of the component detachment nor retrieval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1528319-2018-00030 |
| MDR Report Key | 7852897 |
| Date Received | 2018-09-06 |
| Date of Report | 2018-09-06 |
| Date of Event | 2018-08-06 |
| Date Mfgr Received | 2018-08-08 |
| Device Manufacturer Date | 2017-04-22 |
| Date Added to Maude | 2018-09-06 |
| 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 | GUARDUS OVERTUBE - GASTRIC |
| Generic Name | OVERTUBE |
| Product Code | FED |
| Date Received | 2018-09-06 |
| Model Number | 00711148 |
| Catalog Number | 00711148 |
| Lot Number | 1706716 |
| 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 | 2018-09-06 |