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

Model Number OPMI PENTERO

Device Problems Use of Incorrect Control/Treatment Settings (1126); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Radiation Burn (1755); Partial thickness (Second Degree) Burn (2694)

Event Date 01/09/2014

Event Type  Injury  

Event Description

The site reported that the pt received a burn during spinal untethering and laminectomy procedure performed using the opmi pentero microscope.The burn was described as "mid to deep partial thickness" which is 5 cm x 4 cm x 0.5 cm deep centered around the incision.The pt is under going care.

Manufacturer Narrative

A field service engineer (fse) performed an on-site inspection.The microscope, including light related functions, was found to be within specifications.The surgery time was approximately 3 hours.The distance between light source and pt was 30 cm.The light intensity was set at 98%.The user manual states: "a warning is displayed on the touchscreen and in the data injection system when the threshold value of 25% is exceeded, informing the user of possible tissue damage when the light intensity is too high" and "if the xenon light is not used as intended, excessive illumination intensity may result in third-degree burns".The user manual also has a 3-page section titled "risk of burn injuries caused by high illumination intensity".The site also reported that ioban incision drapes were used.The user manual states "the interaction of heat and microbial substances in incision foils may lead to an increased reaction of the pt to these substances." the site contact is the same as the initial reporter.

• Brand Name: OPMI PENTERO
• Type of Device: MICROSCOPE, SURGICAL, GENERAL & PLA
• Manufacturer (Section D): CARL ZEISS MEDITEC AG; oberkochen ; GM
• Manufacturer (Section G): CARL ZEISS MEDITEC AG; carl zeiss strasse 22; oberkochen 7344 7; GM 73447
• Manufacturer Contact: judy brimacombe ; 5160 hacienda drive; dublin, CA 94568 ; 9255574616
• MDR Report Key: 3640747
• MDR Text Key: 16449892
• Report Number: 9615010-2014-00005
• Device Sequence Number: 1
• Product Code: EPT
• 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,User Facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OPMI PENTERO
• Device Catalogue Number: 302582-9901-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2011
• 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
• Patient Outcome(s): Other
• Patient Age: 11 MO
• Patient Weight: 5