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 Problem Full thickness (Third Degree) Burn (2696)

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"; 35:227-233.This information was originally included in medwatch manufacturer report no.9615010-2014-00009 submitted on june 18, 2014.In case 4, a patient with fitzpatrick skin type ii underwent an intact canal wall tympanomastoidectomy for primary acquired cholesteatoma using an opmi pentero microscope.The xenon light source was used for a cumulative time of 85 minutes at 100% intensity and a 250mm focal length.The following day, a third-degree burn was noted over the left helical rim and antihelix.A course of prophylactic oral antibiotics and topical mupirocin ointment were provided.The outcome: loss of cartilage with cosmetic deformity.

Manufacturer Narrative

Narrative: the main author, dr.Carlson, stated that there was no add'l info beyond the article.It was reported that the patient was exposed to 85 minutes of illumination at a 100% intensity and a 250 mm focal length.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 info in the article, it can be concluded that the third-degree burn experienced by the patient was the result of use not in accordance with 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); rudolf-eber-strasse 11; oberkochen D-73 44; GM D-7344
• Manufacturer Contact: judy brimacombe ; hacienda drive; dublin, CA 94568 ; 9255574616
• MDR Report Key: 4033384
• MDR Text Key: 22263233
• Report Number: 9615010-2014-00016
• 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: Literature
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 25 YR