MAUDE Adverse Event Report: SMITH NEPHEW, INC. N/A; ACCESSORIES,ARTHROSCOPIC

Model Number 8360-10

Device Problems Break (1069); Difficult to Open or Close (2921); Physical Resistance/Sticking (4012)

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

Event Date 04/04/2019

Event Type  malfunction  

Event Description

Davis and geck laparoscopic grasper being used for two separate cases where the grasper would not close while in patient and could not be withdrawn out of trocar from patient.Trocar and instrument were withdrawn.Once on back table the grasper broke into pieces at the jaw.

• Brand Name: N/A
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH NEPHEW, INC.; 130 forbes blvd.; 120 forbes blvd.; mansfield MA 02048
• MDR Report Key: 8554524
• MDR Text Key: 143229398
• Report Number: 8554524
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8360-10
• Device Catalogue Number: 8360-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/09/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1