MAUDE Adverse Event Report: KARL STORZ ENDOVISION ELECTRONIC ENDOFLATOR; INSUFFLATOR

Model Number 26430520-1

Device Problem Gas/Air Leak (2946)

Patient Problem Pneumothorax (2012)

Event Date 01/22/2019

Event Type  Injury  

Manufacturer Narrative

Per our evaluation findings: the manifold has an internal co2 leak.The manifold needs to be rebuilt due to wear and tear.The power supply is faulty and damaged.(solder joints) the power harness needs to be upgraded.The control board is faulty and it needs to be replaced due to wear and tear.The unit was manufactured in 2005 and has been in use for over 14 years; it shipped to customer in october 2005 and this is the first time they have sent it in for service.

Event Description

Allegedly, during a gastric sleeve procedure, the patient developed a pneumothorax.

• Brand Name: ELECTRONIC ENDOFLATOR
• Type of Device: INSUFFLATOR
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 8410539
• MDR Text Key: 138503310
• Report Number: 1221826-2019-00028
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04048551068793
• UDI-Public: 4048551068793
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 26430520-1
• Device Catalogue Number: 26430520-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2005
• 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