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

Model Number	176613
Medical Device Problem Codes	Detachment Of Device Component (1104); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
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.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that the clevis piece was broken on one side.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.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.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 or Problem Description
According to the reporter per additional information received both blades were retrieved from the patient.They were removed via the laparoscopic ports that were already in site.
Additional Manufacturer Narrative
Corrected information: no eval explain code.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO RETRACT
• Common Device Name: RETRACTOR
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 6619878
• Report Number: 2647580-2017-05547
• Device Sequence Number: 10925127
• Product Code: GAD
• UDI-Device Identifier: 10884523000849
• UDI-Public: 10884523000849
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K914190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 176613
• Device Catalogue Number: 176613
• Device Lot Number: P6J0836X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Initial Date Received by Manufacturer: 05/12/2017
• Supplement Date Received by Manufacturer: 07/07/2017; 07/07/2017
• Initial Report FDA Received Date: 06/07/2017
• Supplement Report FDA Received Date: 08/07/2017; 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other