MAUDE Adverse Event Report: MEDLINE TROCAR

Lot Number 207738

Device Problems Break (1069); Device Damaged Prior to Use (2284); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 01/13/2015

Event Type  malfunction  

Event Description

Upon opening a trocar for a case, a piece of it was broken and fell into basin.The trocar was a reprocessed device by medline.Along with a broken piece, the plastic on the trocar has tiny cracks in it.This item was not used after inspection.This is the second such trocar pulled for cases in 2 days.Central supervisor notified, all trocars with lot number 207738 from shelf.

• Brand Name: TROCAR
• Type of Device: TROCAR
• Manufacturer (Section D): MEDLINE
• MDR Report Key: 5347445
• MDR Text Key: 35246353
• Report Number: MW5058912
• Device Sequence Number: 1
• Product Code: DRC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 207738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other