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

Model Number	176613
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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: occurred during a laparoscopic nephrectomy.There was something black noticed inside the patient.The surgeon removed the foreign material, which was a component of the retracting tool being used.The device was examined to ensure that all disengaged components were removed from the patient.No known impact or consequence to patient.
Additional Manufacturer Narrative
Section evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that the clevis pieces was broken and on both sides of the instrument.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.A review of the current complaint data reveals no trend for a device related failure for this condition.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.

• 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: 6851222
• Report Number: 2647580-2017-06479
• Device Sequence Number: 1523003
• Product Code: GAD
• UDI-Device Identifier: 20884523000846
• UDI-Public: 20884523000846
• 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,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 176613
• Device Catalogue Number: 176613
• Device Lot Number: P5J0208X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Initial Date Received by Manufacturer: 08/10/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1