MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY THERMOFLATOR; INSUFFLATOR

Model Number 26432020-1

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

Patient Problems Hypoventilation (1916); Occlusion (1984)

Event Date 12/02/2016

Event Type  Injury  

Manufacturer Narrative

The device was evaluated and device passed safety test and all pressure and flow readings are within the specification.Per the hospital, the patient was obese, and the event may have been related to patient's anatomy.

Event Description

Allegedly, the patient underwent a laparoscopic hysterectomy procedure and while being insufflated, the patient could not be ventilated and coded.The procedure was stopped to treat the patient, and it was decided to convert to an open procedure.The patient condition post-op was fine.

• Brand Name: THERMOFLATOR
• Type of Device: INSUFFLATOR
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen
• Manufacturer (Section G): KARL STORZ GMBH & CO, KG; mittlestrasse 8; 78503; tuttlingen, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 6313181
• MDR Text Key: 66860244
• Report Number: 9610617-2017-00013
• 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,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/08/2017

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
• Device Operator: Physician
• Device Model Number: 26432020-1
• Device Catalogue Number: 26432020-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: Yes
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2017
• Initial Date Manufacturer Received: 12/15/2016
• Initial Date FDA Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2009
• 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): Life Threatening
• Patient Age: 44 YR
• Patient Weight: 95