MAUDE Adverse Event Report: KARL STORZ MARYLAND INSULATED LAPAROSCOPY DISSECTOR / GRASPER; LAPAROSCOPIC MARYLAND

Model Number 30310MDS

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 07/10/2018

Event Type  Injury  

Event Description

This problem occurred in patient's stomach.During an operation, the "laparoscopic maryland" (the device) was used along with a part of the device called a "distal end of 4 mm trocar." in the patient's stomach, large pieces of the device broke into smaller pieces and fine thread.The device was immediately replaced.The doctor searched the patient's stomach and removed all visible pieces of the device before closure.

• Brand Name: MARYLAND INSULATED LAPAROSCOPY DISSECTOR / GRASPER
• Type of Device: LAPAROSCOPIC MARYLAND
• Manufacturer (Section D): KARL STORZ; el sequndo CA 90245
• MDR Report Key: 7717754
• MDR Text Key: 115103207
• Report Number: MW5078564
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/19/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 30310MDS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention