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

Model Number 711177

Device Problem Insufficient Information (3190)

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

Event Date 03/08/2022

Event Type  malfunction  

Event Description

The user facility reported via user facility medwatch report mw5108030 that their raptor grasping device would not work when taken out of the package.No report of patient harm.

Manufacturer Narrative

Steris endoscopy has made several attempts to obtain additional information regarding the subject event however, the user facility has not responded.The device subject of the event was not returned for evaluation.Without the returned device the root cause of the reported event cannot be determined.The instructions for use packet (ifu 731747) lists warnings and precautions when using the raptor® grasping device, "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." the device history record was reviewed, and no abnormalities were identified.A 3-year complaint review for this lot indicates this to be an isolated occurrence.No additional issues were noted.

Manufacturer Narrative

The device subject of the event was returned for evaluation.Steris endoscopy evaluated the device by actuating the handle and confirming that the jaws properly opened and closed; no issues were noted.Based on the evaluation, it was found that the device was operating properly.A complaint review for this lot indicates this to be an isolated event.No additional issues have been noted.A steris product specialist offered in-service training on proper use of the raptor grasping device and the user facility declined this offer.

• Brand Name: RAPTOR GRASPING DEVICE
• Type of Device: GRASPING DEVICE
• 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: 14288355
• MDR Text Key: 290802663
• Report Number: 1528319-2022-00024
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 00724995183653
• UDI-Public: 00724995183653
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 711177
• Device Catalogue Number: 711177
• Device Lot Number: 2200981
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2022
• 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