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	11/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic procedure, a piece of the equipment had become detached from the instrument, and was retrieved using a grasper and removed from the surgical area.The device retractor was immediately removed from surgery, bagged, broken piece was placed in a specimen pot and into bag.A new instrument was opened in order to complete the case.
Additional Manufacturer Narrative
Correction: evaluation summary: post market vigilance (pmv) led an evaluation of one device.Clevis piece was broken along plane of pin attachment.Distal end of handle was split open.Shaft had disengaged from handle of device.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Replication of the reported condition may occur as a result of the instrument being forced beyond it 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 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.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: 7089552
• Report Number: 2647580-2017-08452
• Device Sequence Number: 1669488
• 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,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2018

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: 01/31/2022
• Device Model Number: 176613
• Device Catalogue Number: 176613
• Device Lot Number: P7A0094X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Initial Date Received by Manufacturer: 11/13/2017
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1