MAUDE Adverse Event Report: TELEFLEX TELEFLEX LAPAROSCOPIC LIVER RETRACTOR

Catalog Number 728148

Device Problems Break (1069); Component Falling (1105)

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

Event Date 02/01/2018

Event Type  Injury  

Event Description

During a laparoscopic cholecystectomy one blade of a teleflex laparoscopic fan retractor catalog #728148 broke off of the retractor and fell into the patient's abdominal cavity. The piece was immediately retrieved by the surgeon and all pieces were accounted for. The retractor and broken blade were retained for inspection if necessary.

• Brand Name: TELEFLEX
• Type of Device: LAPAROSCOPIC LIVER RETRACTOR
• Manufacturer (Section D): TELEFLEX; limerick PA
• MDR Report Key: 7305675
• MDR Text Key: 101499283
• Report Number: MW5075601
• Device Sequence Number: 1
• Product Code: PKE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 728148
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 02/28/2018 Patient Sequence Number: 1