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

Model Number	711177
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 1528319-2022-00024
• Device Sequence Number: 1531983
• Product Code: OCZ
• UDI-Device Identifier: 00724995183653
• UDI-Public: 00724995183653
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown