MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. ISNARE SYSTEM - OVAL SNARE

Model Number 00711086

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/07/2020

Event Type  malfunction  

Manufacturer Narrative

The user facility has indicated that both the active cord and the electrosurgical generator involved in this case have been found to be working correctly.The device subject of this event was not returned to steris endoscopy for evaluation.The user facility was unable to provide the lot number of the subject device.The instructions for use include the following statements: "care must be exercised when using electrocautery instruments to minimize the risk of patient injury.Safe and effective cautery is dependent on factors under the control of the user, as well as equipment design and its adequate inspection and maintenance." steris endoscopy has provided in-service training to the user facility on the use of the isnare device.No additional issues have been reported.

Event Description

The user facility reported that there was insufficient cautery when using an isnare device for a resection of a large, broad based polyp.A bleed at the site of the resection was reported and was treated with the application of hemostatic clips and the procedure was completed.The user stated that it was unclear whether the bleeding was due to insufficient cautery or the nature of the resected polyp.

• Brand Name: ISNARE SYSTEM - OVAL SNARE
• Type of Device: ISNARE
• 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: 10521156
• MDR Text Key: 208123931
• Report Number: 1528319-2020-00030
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 00711086
• Device Catalogue Number: 00711086
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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