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

Model Number 26432020-1

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hematoma (1884); Laceration(s) (1946)

Event Date 03/09/2017

Event Type  Injury  

Manufacturer Narrative

The device is being returned for evaluation but has not yet been received.

Event Description

Allegedly, the patient underwent a laparoscopic procedure and while being insufflated, the hospital claims the thermoflator unit somehow created a vacuum situation, causing the veress needle to perforate/lacerate a blood vessel, creating a hematoma which they were able to evacuate.The patient was admitted overnight and was discharged the following day.

• 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: 6473587
• MDR Text Key: 72177406
• Report Number: 9610617-2017-00028
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04048551069264
• UDI-Public: 4048551069264
• 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: 04/07/2017,03/10/2017

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention
• Patient Age: 17 MO
• Patient Weight: 11