MAUDE Adverse Event Report: STERIS SLIDELOCK ATRAUMATIC GRASPER

Model Number	88-8335
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that the tip of their slidelock atraumatic grasper "broke off" inside of the patient.No report of injury.
Additional Manufacturer Narrative
The slidelock atraumatic grasper subject of the reported event was returned for evaluation.Evaluation results determined that there were deep groves from pliers or a similar tool on both sides of the clevis.This breakage is not indicative of normal use.The damage to the clevis indicates the device was misused and/or third-party modifications were performed resulting in the jaw coming apart as described in the initial reported event.The jaw coming apart is most likely attributed from it being pulled apart from the clevis by excessive force.Steris performed in-service training on the proper use and operation of the slidelock atraumatic grasper and the importance of proper handling.The device history record was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.No additional issues have been reported.

• Brand Name: SLIDELOCK ATRAUMATIC GRASPER
• Common Device Name: GRASPER
• Manufacturer (Section D): STERIS; 5960 heisley rd; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 19623344
• Report Number: 1527821-2024-00004
• Device Sequence Number: 8084421
• Product Code: GEI
• UDI-Device Identifier: 10885403219924
• UDI-Public: (01)10885403219924(10)B23VEO
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 88-8335
• Device Catalogue Number: 88-8335
• 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: 05/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown