MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONYAIR M-SERIES SURGICAL LIGHTING SYSTEM

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

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

Event Type  malfunction  

Manufacturer Narrative

The customer is conducting an investigation as follow-up to five procedures where discoloration of the patient's skin was observed.The reported discoloration was temporary; one of the five patients received a gauze dressing.It was explained to us by the facility personnel that this was not a burn, but rather a temporary "tanning" of the skin.Steris understands the hospital is reviewing all their pre-procedural standard operating procedures, including their techniques for skin preparation.The customer contacted steris asking we perform an evaluation of the lights in an attempt to rule out the lights as the root cause of the reported skin discoloration.Steris has requested additional details regarding the conditions surrounding the reported events; however, the user facility has not provided the complete information requested at this time.A steris service technician inspected the facility's surgical lights.The technician tested the control and operation of the lights; he also tested the intensity levels (power outputs) of the lights; no issues were identified, and no repairs were made.The lights were confirmed to be operating according to specification and returned to service.It was noted however that upon start-up of the lights during the technician's inspection, it was identified that 15 out of 19 lights were set at the highest intensity.Per the operator manual, setting the light to the highest intensity and overlapping the light fields can create too much heat.Specifically, the harmonyair m series surgical lighting system operator manual states (i), "the user of surgical lights should utilize the lowest possible illumination level suitable for the procedure, especially in certain neurological or intestinal procedures on delicate, thin, dry or abnormal tissue.Furthermore, for the protection of surgically exposed tissues and for the comfort and efficiency of the surgeon and assistants, radiant energy can be effectively controlled by limiting the time of exposure at higher illumination levels.Extra care must be taken when the light fields from multiple lightheads are overlapped on the surgical site, since this condition creates a risk of too much heat." a steris account manager performed in-service training with user facility personnel on the proper use and operation of the lighting system.A 2-year complaint review determined this event to be isolated to this facility.A follow-up mdr will be submitted should the user facility provide additional information regarding their pre-procedural standard operating procedures, including their techniques for skin preparation and the conditions surrounding the reported events.

Event Description

The user facility contacted steris requesting functional testing of their harmonyair m-series surgical lights.

• Brand Name: HARMONYAIR M-SERIES SURGICAL LIGHTING SYSTEM
• Type of Device: LIGHTING SYSTEM
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery, al
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery, al
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, oh ; 3927453
• MDR Report Key: 10320922
• MDR Text Key: 209027976
• Report Number: 1043572-2020-00032
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 07/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1