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

Model Number 173046

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, pre-operatively, there were four devices, and each has ripped upon retracting into sheath.There was no patient involvement.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.A visual inspection of the returned product noted that the devices had damaged fabric paddle covers.Exposed deformation of the shafts of the introducers was observed.A functional evaluation found that the paddles were difficult to fully close due to the damage of both the shafts and paddle covers.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 damaged paddle retractor cover may occur when either the paddle retractor is retracted with the paddle in a partially open state; pushing the introducer forward over a paddle that is not fully closed may cause stretching and breakage of the introducer; or if the paddle retractor is subjected to excessive manipulation or used for leverage, these forces may cause the tearing of the cover/ cloth.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• 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: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 9360480
• MDR Text Key: 167592718
• Report Number: 2647580-2019-05732
• 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,Followup
• Report Date: 03/09/2020

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 Model Number: 173046
• Device Catalogue Number: 173046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/22/2019
• Supplement Dates Manufacturer Received: 02/20/2020
• Supplement Dates FDA Received: 03/09/2020
• 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