MAUDE Adverse Event Report: KARL STORZ; SLOT GRASPER

Model Number INSO

Device Problems Detachment of Device or Device Component (2907); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2015

Event Type  malfunction  

Event Description

Laparoscopic slot grasper used malfunctioned during surgery, surgeon assessed and determined that the tip had come apart.A piece of metal approx half a centimeter was dislodging from the lumen of the sheath.

• Type of Device: SLOT GRASPER
• Manufacturer (Section D): KARL STORZ
• MDR Report Key: 5327204
• MDR Text Key: 34436887
• Report Number: MW5058728
• Device Sequence Number: 3
• Product Code: GCJ
• 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: 12/21/2015
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: INSO
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR