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

Model Number 173046

Device Problems Difficult to Insert (1316); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/03/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the shaft of the instrument was broken.It was reported that the user experienced difficulty in insertion of the device to or from the port and the jaws of the reload faced resistance prior to closing fully.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur when the device is leveraged and exposed to an improper or excessive force.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during laparoscopic sleeve gastrectomy, the device would not twist / close to insert into port.The device never touched the patient.The surgeon then used another device to resolve the issue in order to complete the case.There was no patient 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 11916764
• MDR Text Key: 253752898
• Report Number: 2647580-2021-01848
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 10884523000771
• UDI-Public: 10884523000771
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914190
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 173046
• Device Catalogue Number: 173046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 35 YR