MAUDE Adverse Event Report: MEDTRONIC HASSON; TROCAR

Device Problems Break (1069); Material Separation (1562)

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

Event Date 05/14/2019

Event Type  malfunction  

Event Description

Surgeon first used the hasson trocar from another manufacturer, but the white clip broke while he was trying to release the sleeve.Nothing broke inside the abdomen at the time.Then, the surgeon used a trocar from applied medical to complete the surgery, but when surgeon was trying to take this trocar out of the abdomen, the trocar hub came apart in five pieces, and a small white piece dropped into the abdomen.The surgeon was able to retrieve the small white piece prior to closure.Pictures of both of these trocars are available.Unfortunately, the reference number and lot numbers are not available.

• Brand Name: HASSON
• Type of Device: TROCAR
• Manufacturer (Section D): MEDTRONIC; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 9075282
• MDR Text Key: 158811299
• Report Number: 9075282
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 09/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22995 DA
• Patient Weight: 132