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

Model Number 26432020-1

Device Problem Decrease in Pressure (1490)

Patient Problem Burn, Thermal (2530)

Event Date 10/26/2017

Event Type  Injury  

Manufacturer Narrative

The insufflator unit was not returned for evaluation.There was no report of a malfunction of the insufflator.

Event Description

Allegedly, as per a summons received by karl storz, during a laparoscopic left salpingo-oophorectomy and hysteroscopic d&c procedure, pneumoperitoneum was lost, secondary to low air in the tank and equipment readjustment.During the period of time where the pneumoperitoneum was lost, a thermal injury to the patient's descending/proximal sigmoid colon occurred, which likely weakened the tissue.

• 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: 9288462
• MDR Text Key: 165373238
• Report Number: 9610617-2019-00105
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/05/2019

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: Health Professional
• Device Model Number: 26432020-1
• Device Catalogue Number: 26432020-1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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