MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO PADDLE RETRACT; RETRACTOR

Model Number 173046

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 05/10/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The event report alleges the product was used in a surgical procedure.The outer tubing wad damaged and disengaged from the device.The paddle had tears in it.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the reported condition may be due to rough handling of the device during use.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.No relationship between the device and the reported incident was confirmed.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

Event Description

According to the reporter: occurred during a laparoscopic nissen procedure.The retractor got stuck when removing the outer sheath/needle.Opened another device but the same issue occurred.Opened a third device and the same issue occurred, but the device was able to be used.There was no patient harm.The patient status is alive, no injury.

• Brand Name: ENDO PADDLE RETRACT
• Type of Device: RETRACTOR
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: sharon murphy ; 60 middletown avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6746412
• MDR Text Key: 81125288
• Report Number: 2647580-2017-05765
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 10884523000771
• UDI-Public: 10884523000771
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 173046
• Device Catalogue Number: 173046
• Device Lot Number: P5K0834X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2017
• Date Device Manufactured: 10/29/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1