MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO RETRACT II; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 176647

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, fan retractor broke during laparoscopic prostatectomy.Small pieces of plastic from the retractor fell inside the patient and these were removed immediately once identified by the surgeon.A new fan retractor was used to complete the case.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.A visual inspection of the returned product noted that the clevis fixture was broken on both sides of the product.A functional evaluation found that the device articulated properly and without difficulty.The device fanned out properly and without difficulty.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 occur because of the instrument being forced beyond its indicated use due to applying excessive stress over the clevis.The plastic clevis was broken from the pin hole; which is consistent with the use of excessive force during the procedure, thus causing the unit clevis to break and the distal end of the handle to partially split open.The root cause of the observed damage was due to the product not being used as indicated 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 RETRACT II
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 9504036
• MDR Text Key: 172409366
• Report Number: 2647580-2019-06263
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884523000856
• UDI-Public: 10884523000856
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K920068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/23/2020

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 Expiration Date: 05/31/2024
• Device Model Number: 176647
• Device Catalogue Number: 176647
• Device Lot Number: P9F1099Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 01/10/2020
• Supplement Dates FDA Received: 01/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2019
• 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