MAUDE Adverse Event Report: CLARITY MEDICAL SYSTEMS, INC. RETCAM SHUTTLE; OPHTHALMIC CAMERA

Model Number RETCAM SHUTTLE

Device Problems Crack (1135); Use of Device Problem (1670); Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2015

Event Type  malfunction  

Manufacturer Narrative

The customer, (b)(6) hospital medical center, purchased a retcam shuttle system (rs 6401) and rop lens (model d1300 serial (b)(4)) in (b)(6) 2014.The unit was installed on (b)(4) 2014.User training was performed by clarity personnel on may 2, 2014.The unit was provided with a retcam shuttle user manual (p/n 18-000393 rev a).On june 30, 2015, (b)(6) called into clarity that "the seam along the top of the camera is splitting.".New handpiece covers were subsequently provided to (b)(6).There were no patient injuries.Pictures of the suspect handpiece were available for review.The alleged cracks were confirmed and the cracks were indicative of a mechanical fracture and not chemical crazing.The retcam handpiece is not intended and is unlikely to contact the patient eye or mucous membranes.The clarity user manual informs the user to use good public health practices when handling the equipment, based on cdc guidelines.The (b)(6) suggest cleaning instruments (that may come into contact with patients) with alcohol or bleach and does not mention disinfection.(b)(4) were suggested to the customer for use.We received an e-mail from (b)(6) on 10/28/2015 that the handpiece with the replaced shells is working fine.Clarity considers the matter closed.(b)(4).

Event Description

Dignity health reported through medwatch, issue with retcam handpiece.Camera handset was noted to have splitting at the seam and cracking running off from the seam.Moreover, the hospital infection control department needs high level disinfection for all medical instruments that come in contact with mucous membranes and the retcam instructions for use (ifu) does not provide disinfectants that could be used on the machine including the handset.

• Brand Name: RETCAM SHUTTLE
• Type of Device: OPHTHALMIC CAMERA
• Manufacturer (Section D): CLARITY MEDICAL SYSTEMS, INC.; 5775 west las positas blvd; suite 200; pleasanton CA 94588 4084
• Manufacturer (Section G): CLARITY MEDICAL SYSTEMS, INC.; 5775 west las positas blvd; suite 200; pleasanton CA 94588 4084
• Manufacturer Contact: eric steuben ; 5775 west las positas blvd; suite 200; pleasanton, CA 94588-4084 ; 9254637984
• MDR Report Key: 5394963
• MDR Text Key: 36957843
• Report Number: 2952489-2016-00002
• Device Sequence Number: 1
• Product Code: HKI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RETCAM SHUTTLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1