MAUDE Adverse Event Report: APPLIED MEDICAL TROCAR SLEEVE

Catalog Number CFS02

Device Problem Deflation Problem (1149)

Patient Problem No Information (3190)

Event Date 12/22/2014

Event Type  No Answer Provided  

Event Description

During laparoscopic cholecystectomy balloon on trocar would not deflate when a syringe was used.This was attempted several times.

• Brand Name: TROCAR SLEEVE
• Type of Device: TROCAR
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 4462256
• MDR Text Key: 19308514
• Report Number: 4462256
• Device Sequence Number: 2
• Product Code: DRC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 12/29/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Invalid Data
• Device Catalogue Number: CFS02
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2015
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2015
• Patient Sequence Number: 1
• Patient Age: 43 YR