MAUDE Adverse Event Report: KARL STORZ SE & CO. KG THERMOFLATOR; INSUFFLATION DEVICE

Model Number	26432020-1
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
The initial complaint report noted the following: our thermoflator unit was used for vein harvesting procedures on (b)(6) of 2021 (and potentially two more).The unit is in or15.Surgeon in all 3 cases was dr.(b)(6).Customer did not provide specific information on the incident.However, per the customer, the insufflator is working according to the equipment's specifications.The issue that they have identified is a potential user error with the insufflator.The user had the pressure and the flow settings much higher than he should have during the endoscopic vein harvesting.Per our complaint investigation, the customer stated: after endoscopic vein harvesting started, the patient's end tidal co2 started to rise.Anesthesia machine showed increase in etco2.Patient's blood gas showed an increase in pco2.Efforts were made to correct the co2, but it did not decrease until about 1.5 hour when endoscopic vein harvesting was finishing.Anesthesia machine settings were changed in order to lower etco2 (increase respiratory rate and changed out all hoses and filters on machine).Interventions didn't help initially.No patient impact or injury identified.Customer also stated that they are exploring user variation with co2 settings on the insufflator as a possible cause.In addition to the three cases mentioned above, customer has confirmed there were an additional two cases in (b)(6) 2021; however, they could not provide specific dates for those cases, but they believe there was no negative patient impact in those cases as well.This report is for the (b)(6) 2021 case.
Additional Manufacturer Narrative
Per the evaluation findings: the flow rates and pressure readings are within manufacturing specifications.However, the comparator circuitry for pressure has drifted more then 3 places from reference.A new control board is needed.The thermoflator unit originally shipped to the customer in (b)(6) 2013 and had not been previously returned for repair or evaluation.
Additional Manufacturer Narrative
Per the evaluation findings: the flow rates and pressure readings are within manufacturing specifications.However, the comparator circuitry for pressure has drifted more then 3 places from reference.A new control board is needed.The thermoflator unit originally shipped to the customer in (b)(6) 2013 and had not been previously returned for repair or evaluation.
Event or Problem Description
The initial complaint report noted the following: our thermoflator unit was used for vein harvesting procedures on (b)(6) of 2021 (and potentially two more).The unit is in or15.Surgeon in all 3 cases was dr.(b)(6).Customer did not provide specific information on the incident.However, per the customer, the insufflator is working according to the equipment's specifications.The issue that they have identified is a potential user error with the insufflator.The user had the pressure and the flow settings much higher than he should have during the endoscopic vein harvesting.Per our complaint investigation, the customer stated: after endoscopic vein harvesting started, the patient's end tidal co2 started to rise.Anesthesia machine showed increase in etco2.Patient's blood gas showed an increase in pco2.Efforts were made to correct the co2, but it did not decrease until about 1.5 hour when endoscopic vein harvesting was finishing.Anesthesia machine settings were changed in order to lower etco2 (increase respiratory rate and changed out all hoses and filters on machine).Interventions didn't help initially.No patient impact or injury identified.Customer also stated that they are exploring user variation with co2 settings on the insufflator as a possible cause.In addition to the three cases mentioned above, customer has confirmed there were an additional two cases in (b)(6) 2021; however, they could not provide specific dates for those cases, but they believe there was no negative patient impact in those cases as well.This report is for the (b)(6) 2021 case.

• Brand Name: THERMOFLATOR
• Common Device Name: INSUFFLATION DEVICE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: anja fair ; 13803 n. promenade blvd.; stafford, TX 77477
• MDR Report Key: 12870738
• Report Number: 9610617-2021-00082
• Device Sequence Number: 5749257
• Product Code: HIF
• UDI-Device Identifier: 04048551069264
• UDI-Public: 4048551069264
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K955073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 26432020-1
• Device Catalogue Number: 26432020-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown