MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY AMERICA, INC KARL STORZ GMBH & CO. OPTITHERM HEATING ELEMENT; INSUFFLATOR, LAPAROSCOPIC

Model Number OPITHERM

Device Problems Defective Alarm (1014); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 12/21/2020

Event Type  Injury  

Event Description

The patient, during laparoscopic surgery, sustained a burn on her abdomen from an overheated insufflator optitherm heating element (used to warm up co2 as it travels into the abdominal cavity).The patient was assessed by plastic surgery and no interventions needed.Silvadene applied for the superficial burn and as of note, the burn is healing well and no signs of necrosis.Background use: the insufflator provides co2, which passes through a heating module called the optitherm.This is supposed to bring the gas to approximately 98 degrees f before going into the patient.If the gas exceeds 105.8 degrees f, a continuous alarm should sound and the optitherm unit shut off automatically.A symbol for the optitherm on the front panel of the equipment will also light up red.The unit was interrogated by the biomed team and it was verified with a thermometer that the temp module was in fact overheating (thermometer showed 120 degrees f), however, the system did not alarm.We'll do some more troubleshooting tomorrow and see if we can pinpoint the failure (insufflator side, optitherm side, or both).Some notes about this specific insufflator: unit was purchased in 2009 outside of annual maintenance, there have been no issues or corrective action required for this unit, unit is up to date on its preventive maintenance there are no logs or recordings available on the equipment, so, we are not able to check failure points, temperatures, or previous alarms.Fda safety report id # (b)(4).

• Brand Name: KARL STORZ GMBH & CO. OPTITHERM HEATING ELEMENT
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): KARL STORZ ENDOSCOPY AMERICA, INC; el segundo CA 90245
• MDR Report Key: 11207362
• MDR Text Key: 228214526
• Report Number: MW5098901
• Device Sequence Number: 1
• Product Code: HIF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPITHERM
• Device Catalogue Number: 204320 30
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 89