MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG OPMI PENTERO; MICROSCOPE SURGICAL GENERAL & PLASTIC

Model Number PENTERO

Device Problems Use of Incorrect Control/Treatment Settings (1126); Use of Device Problem (1670)

Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Event Description

This is one of four adverse events reported in the article: "auricular burns associated with operating microscope use during otologic surgery"; latuska, richard f.Et al.; otology & neurology 2014; 35:227-233.This information was originally included in medwatch manufacturer report no.9615010-2014-0009 submitted on (b)(6) 2014.In case 1, a patient with fitzpatrick skin type ii underwent a transcanal middle ear exploration with stapedotomy using an opmi pentero microscope.The xenon light source was used for a cumulative time of 75 minutes at 70% intensity and a 300 mm focal length.Two hours after surgery, increasing erythema was noted over the antihelix, and a serious bulla developed on the lobule of the ear.The severity was reported as first-degree and second-degree burns.The wound was managed with warm soapy water and application of vaseline ointment.The outcome: minor scar.

Manufacturer Narrative

The main author, dr.Carlson, stated that there was no additional information beyond the article.It was reported that the patient was exposed to 75 minutes of illumination at a 70% intensity and a 300 mm focal length.The user manual explains in detail the risks of burns, including 3rd-degree burns, caused by high illumination intensity.The user manual instructs the user to set the illumination intensity to the minimum value required with 25% recommended as a starting value.A visual warning can be displayed when an illumination threshold value is exceeded.The default factory threshold is set to be active with a value of 25%.The user manual also describes the contribution of focal distance, time and patient skin type to burns.Finally the user manual discusses the susceptibility of skin around the incision to burns with a recommendation to use wet gauze in the area to reduce the chance of burns.Based upon the information in the article, it can be concluded that first and second-degree burns experienced by the patient were the result of use not in accordance wit the user documentation.

• Brand Name: OPMI PENTERO
• Type of Device: MICROSCOPE SURGICAL GENERAL & PLASTIC
• Manufacturer (Section D): CARL ZEISS MEDITEC AG; oberkochen ; GM
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (OBERKOCHEN SITE); rudolof-eber-strasse 11; oberkochen D-73 44; GM D-7344
• Manufacturer Contact: judy brimacombe ; 5160 hacienda drive; dublin, CA 94568 ; 9255574616
• MDR Report Key: 4032062
• MDR Text Key: 4876370
• Report Number: 9615010-2014-00013
• Device Sequence Number: 1
• Product Code: FSO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PENTERO
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention; Disability
• Patient Age: 17 YR