MAUDE Adverse Event Report: STERIS GRASPING DEVICE; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

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

Event Date 01/25/2024

Event Type  malfunction  

Event Description

Patient in gi(gastro intestinal) procedure to remove food bolus.Provider inserted this device into endoscopy scope to retrieve/remove food bolus.Upon trying to open the device, gi tech was unable to do so and appeared to be stuck inside.Gi tech attempted to open and close device a few times without the device opening to retrieve the food.The device was removed from the endoscopy scope without harm to patient.

• Brand Name: GRASPING DEVICE
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): STERIS; mentor OH 44060
• MDR Report Key: 18780445
• MDR Text Key: 336321562
• Report Number: MW5151943
• Device Sequence Number: 1
• Product Code: OCZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Hispanic
• Patient Race: White