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

Model Number 176613

Device Problems Detachment Of Device Component (1104); Appropriate Term/Code Not Available (3191)

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

Event Date 05/09/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter: during a laparoscopic nephrectomy, two endo retracts have failed and come apart inside the patient.The blades fell and had to find the missing pieces.The surgical time extended 30 minutes or more due to the product problem.The incision was also extended for more than 1 inch.Patient status: alive - no injury.

Manufacturer Narrative

Post market vigilance (pmv) led an evaluation of one device.The event report alleges the product was used in a surgical procedure.The visual inspection of the returned product noted that the clevis pieces were broken on both sides.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 as a result of the instrument being forced beyond it indicated use.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.A relationship between the device and the reported incident of broken clevis was confirmed.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

Event Description

Both blades were retrieved from the patient.They were removed via the laparoscopic ports that were already in site.

Manufacturer Narrative

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

• Brand Name: ENDO 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 ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6619841
• MDR Text Key: 76938462
• Report Number: 2647580-2017-05546
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 10884523000849
• UDI-Public: 10884523000849
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K914190
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 176613
• Device Catalogue Number: 176613
• Device Lot Number: P6A0164X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2016
• 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 Outcome(s): Other