MAUDE Adverse Event Report: US ENDOSCOPY / UNITED STATES ENDOSCOPY GROUP, INC. STERIS RAPTOR GRASPING DEVICE; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Model Number 00711177

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Raptor grasping device #00711177 lot#2200981 x2.Faulty garbage.Faulty right out of the bag.Fda safety report id #(b)(4).

• Brand Name: STERIS RAPTOR GRASPING DEVICE
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): US ENDOSCOPY / UNITED STATES ENDOSCOPY GROUP, INC.; mentor OH 44060
• MDR Report Key: 13734237
• MDR Text Key: 287247722
• Report Number: MW5108030
• Device Sequence Number: 1
• Product Code: OCZ
• UDI-Device Identifier: 00724995183653
• UDI-Public: (01)00724995183653
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00711177
• Device Catalogue Number: 00711177
• Device Lot Number: 2200981
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1