MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. HISTOLOCK RESECTION DEVICE; SNARE

Model Number 00711117

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2021

Event Type  malfunction  

Manufacturer Narrative

Steris has made several attempts to follow-up with the user facility to fully investigate the reported event.To date, the user facility has not responded.A review of our records indicates that one of the lot numbers (2010696) provided in the medwatch report does not align with a steris endoscopy lot number.There have been no other complaints associated with lot number 1912249.The devices subject of this complaint were not returned to steris endoscopy for evaluation.Without the device or additional user information, the report of device kinking with associated generator shortage could not be assessed.The instructions for use include the following statements, "the following conditions may not allow the device to function properly or cause patient injury: attempting to advance the handle to the open position with too much speed or force, attempting to pass or open the device in an extremely articulated endoscope, attempting to actuate the device in an extremely coiled position and/or, attempting to actuate the device when the handle is at an acute angle in relation to the sheath.If resistance to insertion is encountered, reduce the angulation (or lower the forceps elevator if applicable) until the instrument passes smoothly.Avoid forcefully closing the snare (as evident by sheath collapsing or crushing), without adequate electrocoagulation which can cause bleeding, incomplete cutting, or snare incarceration around the polyp.Check that all electrical connections are correct.Confirm appropriate dispersive electrode position on the patient." no additional issues have been reported.

Event Description

The user facility report via user facility medwatch report mw5100226 that during an endoscopic mucosal resection (emr) performed by a fellow, two histolock resection devices kinked causing a shortage in the electrosurgical generator and resulting in an incomplete endoscopic mucosal resection (emr).There was no report of harm to the patient.

• Brand Name: HISTOLOCK RESECTION DEVICE
• Type of Device: SNARE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 11897785
• MDR Text Key: 256337653
• Report Number: 1528319-2021-00017
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140763
• 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: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 00711117
• Device Catalogue Number: 00711117
• Device Lot Number: 1912249, 2010696
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/27/2021
• 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