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

Model Number 26432020-1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 06/06/2018

Event Type  Injury  

Manufacturer Narrative

The thermoflator unit was evaluated.We found the unit functions properly and the pressure and flow are within specifications.

Event Description

Allegedly, during a laparoscopic procedure, while the patient's abdomen was being insufflated, the thermoflator unit's set pressure was not reading, and the patient became hypotensive.

• Brand Name: THERMOFLATOR
• Type of Device: INSUFFLATOR
• 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: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 7754813
• MDR Text Key: 116208109
• Report Number: 9610617-2018-00060
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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: 06/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2016
• 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