MAUDE Adverse Event Report: RONIN SURGICAL CORP. RONIN SURGICAL CORP; HEADLAMP, OPERATING, BATTERY-OPERATED

Model Number X6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 05/12/2023

Event Type  Injury  

Manufacturer Narrative

As noted in the b.5 response, ronin responded promptly to conduct a thorough investigation.At that time, it also requested information from the surgeon with respect to her use of the device.Based upon its investigation and the surgeon's response to ronin's use questions, ronin can only conclude that its device was not the cause of the reported burn.

Event Description

This incident is the subject of medical device report mw5144689, which was submitted to fda on august 14, 2023 by dr.(b)(6).A copy of this mdr was provided to ronin by fda on september 12, 2023.On may 13, 2023, ronin surgical received an email communication from dr.(b)(6) informing ronin of a surgery performed several days prior during which the patient experienced a burn.A ronin x6 headlight was reportedly used during the procedure.It was further reported that the minimum distance the device was used at was greater than 12 inches from the patient.On or about may 15, 2023, during a phone call between ronin and (b)(6) hospital for children, a mutual decision was made by the parties that the hospital would return the headlight used in the surgery to ronin for evaluation.Ronin received the headlight used in the surgery, its holster, and its battery on or about may 25, 2023.Ronin conducted a manual inspection of the components and found no evidence of physical damage or mechanical abnormality.Ronin also conducted a functional test and found no evidence of abnormal behavior or performance.Thermocouple ("heat rise") testing was also conducted and confirmed that the alleged subject device was performing within specifications and was not defective; ronin therefore ruled out the headlight as a cause of the reported issue.At the hospital's request, ronin provided a report detailing its findings to the hospital on or about june 5, 2023.As of ronin's last communication with (b)(6) hospital for children's vp of quality on or about july 10, 2023, no additional information was provided by the hospital, and the results of the hospital's investigation were that they were not able to determine the cause of the burn.Disclaimer: this information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a ronin surgical product malfunctioned, is defective or has caused serious injury.

• Brand Name: RONIN SURGICAL CORP
• Type of Device: HEADLAMP, OPERATING, BATTERY-OPERATED
• Manufacturer (Section D): RONIN SURGICAL CORP.; 6420 avenida wilfredo; la jolla CA 92037
• Manufacturer (Section G): RONIN SURGICAL CORP.; 6420 avenida wilfredo; la jolla CA 92037
• Manufacturer Contact: clifton learn ; 6420 avenida wilfredo; la jolla, CA 92037 ; 8589978085
• MDR Report Key: 18390532
• MDR Text Key: 331291122
• Report Number: 3013682780-2023-00001
• Device Sequence Number: 1
• Product Code: HPP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: X6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other