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

Model Number	174209
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/08/2018
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, prior to laparoscopic sigmoidectomy, the nurse opened the packaging and checked the device.Slide lever and shaft was found disengaged and the tip was not being able to put in.They used another device to continue.There was no patient involvement.
Additional Manufacturer Narrative
Additional information: evaluation summary: post market vigilance (pmv) led an evaluation of one device.Inner shaft had disengaged from retraction slider; there was no sign of deformation or breakage.The knob component was inspected using a microscope and no indentation around the knob hole was observed.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.However, a manufacturing fault was identified during product analysis.The root cause of the observed condition was determined to be a result of a manufacturing activity.The root cause maybe due to the lack of inspection of the pin to determine proper assembly of the pin after the pin insert machine places the pin inside of the center rod ¿ knob assembly.Due to the fixative nature of the center rod component inside of knob hole, the retraction of the device can be performed and the person assembling would falsely deduce the presence of pin inside of the assembly without it being present.Improvements have been initiated to mitigate this condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO MINI-RETRACT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 7907419
• Report Number: 2647580-2018-04695
• Device Sequence Number: 16557716
• Product Code: GCJ
• UDI-Device Identifier: 10884523000801
• UDI-Public: 10884523000801
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K920068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2018

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: 11/30/2022
• Device Model Number: 174209
• Device Catalogue Number: 174209
• Device Lot Number: P7L1238X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 12/01/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 12/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1