MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. GUARDUS OVERTUBE - GASTRIC

Model Number 00711148

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/06/2018

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: GUARDUS OVERTUBE - GASTRIC
• Type of Device: OVERTUBE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley rd; mentor, OH 44060 ; 4403586251
• MDR Report Key: 7852897
• MDR Text Key: 119655688
• Report Number: 1528319-2018-00030
• Device Sequence Number: 1
• Product Code: FED
• UDI-Device Identifier: 00816765011225
• UDI-Public: (01)00816765011225
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K040836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2020
• Device Model Number: 00711148
• Device Catalogue Number: 00711148
• Device Lot Number: 1706716
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1