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

Model Number	72204725S
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found residue on both windows and the distal window cracked.A functional evaluation did not reveal any problems.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.The complaint was confirmed.Factors that could have contributed to the reported event include the application of inappropriate force.No containment or corrective actions are recommended at this time.
Event or Problem Description
It was reported that, during set up, the "hd coupler 17.2mm" was noticed to be blurry.A backup device was available to complete the procedure.There were no procedural delays and no patient injuries or other complications were reported.Results of investigation have concluded that this unit had a cracked distal window which makes it a reportable event.

• Brand Name: SERVICE REPL COUPLER HD 17.2MM AUTO
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 11907499
• Report Number: 3003604053-2021-00213
• Device Sequence Number: 13705345
• Product Code: GCJ
• UDI-Device Identifier: 00885556632048
• UDI-Public: 00885556632048
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K153606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2021

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: 72204725S
• Device Catalogue Number: 72204725S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 05/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1