MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COUPLER HD 17.2MM AUTOCLAVABLE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	72204725
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during procedure the coupler locking is too tight, coupler comes out of camera head with rotation of scope.No back-up device was available.No patient injury was reported.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product to look at.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.

• Brand Name: COUPLER HD 17.2MM AUTOCLAVABLE
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 7627808
• Report Number: 3003604053-2018-00100
• Device Sequence Number: 1187579
• Product Code: GCJ
• UDI-Device Identifier: 00885556616727
• UDI-Public: (01)00885556616727
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K153606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2018

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 Model Number: 72204725
• Device Catalogue Number: 72204725
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 06/21/2018
• Supplement Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1