MAUDE Adverse Event Report: KARL STORZ GMBH & CO. OPTITHERM HEATING ELEMENT

Model Number 20432030

Device Problems No Audible Alarm (1019); Overheating of Device (1437)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 06/30/2014

Event Type  malfunction  

Event Description

Allegedly, prior to the start of a laparoscopic appendectomy procedure, the optitherm heating element became hot.It was laid on the patient twice while they were plugging in all the cords and the patient sustained two second degree burns.When the burns were noticed, the optitherm cord connection to the thermoflator unit was checked and when the cord was touched, it fell out of the receptacle.They tried plugging it back in but the thermoflator unit sounded an overheating alarm; they, therefore, performed the procedure without using the optitherm.Both burns were treated with antibiotic ointment.The procedure was completed and patient condition post-op was fine.

Manufacturer Narrative

We tested the actual optitherm device and were unable to duplicate the reported issue of overheating; once the optitherm was attached to a thermoflator, the overheating alarm immediately came on even though the optitherm was at room temperature.We have no other reports of this same product issue and suspect the optitherm may have been compromised due to not being properly plugged in to the thermoflator.The optitherm is being returned to the manufacturer for further evaluation; a supplemental report will be sent once the evaluation is available.

• Brand Name: OPTITHERM HEATING ELEMENT
• Type of Device: HEATING ELEMENT
• Manufacturer (Section D): KARL STORZ GMBH & CO.; tuttlingen ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG; mittelstrasse 8; tuttlingen 7850 3; GM 78503
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 4169077
• MDR Text Key: 4873759
• Report Number: 9610617-2014-00036
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20432030
• Device Catalogue Number: SAME
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• 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): Required Intervention
• Patient Age: 30 YR