MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. RAPTOR GRASPING DEVICE

Model Number 00711177

Device Problems Break (1069); Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Date 02/15/2020

Event Type  malfunction  

Manufacturer Narrative

The device subject of this event has not been returned to steris endoscopy for evaluation; however, the distributor has provided photographs of the device and a video of the device being actuated.Contrary to the initial report, examination of photographs and video of device actuation has found no evidence of damage or malfunction.The device history record was reviewed and confirmed the device lot was manufactured to specification.There have been no other complaints associated with this lot.The instructions for use include the following statements: "actuate the device by moving the slider on the handle back and forth to confirm that the grasping jaws open and close smoothly.If the unit does not function properly, or there is evidence of damage (e.G.Bends, kinks, misshapen jaws, misaligned jaws, exposed wires) do not use this product and contact your local product specialist." steris endoscopy has requested that the distributor offer in-service training to the user facility.No further issues have been reported.This report will be updated if additional information becomes available.

Event Description

The distributor reported that a raptor grasping device was damaged prior to use and could not be closed.The device was not used in a procedure nor inserted into the endoscope.The patient had no contact with the device and there was no harm to the patient or user.

• Brand Name: RAPTOR GRASPING DEVICE
• Type of Device: GRASPING DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor, oh
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor, oh
• Manufacturer Contact: coletta cohara ; 5976 heisley rd; mentor, oh ; 3586251
• MDR Report Key: 10346007
• MDR Text Key: 202749475
• Report Number: 1528319-2020-00024
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 00816765011317
• UDI-Public: (01)00816765011317
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K120084
• 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: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2022
• Device Model Number: 00711177
• Device Catalogue Number: 00711177
• Device Lot Number: 1912102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2019
• 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