MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. HIGH FLOW INSUFFLATION TUBING WITH FILTER; TUBING/TUBING WITH FILTER, INSUFFLATION, LAPAROSCOPIC

Catalog Number 20400162S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Bradycardia (1751)

Event Date 08/10/2016

Event Type  malfunction  

Event Description

The physician was performing a laparoscopic oophorectomy.At the start of the procedure she hooked up the veress needle to a storz high flow insufflation tubing (with filter) cat # 20400162s, lot # 117891.The insufflator tubing is used to regulate the now rate and pressure of co2 used to distend the abdomen during laparoscopy.However, the tubing did not work as it should.The pressure in the abdomen was not regulated.The belly was noted to be distended at approximately the same time that the patient's vital signs were also reacting and the patient was becoming bradycardic.The physician immediately disconnected the tubing and deflated the abdomen and the patient's vital signs returned to normal.A new tubing was connected and worked as it was supposed to.

• Brand Name: HIGH FLOW INSUFFLATION TUBING WITH FILTER
• Type of Device: TUBING/TUBING WITH FILTER, INSUFFLATION, LAPAROSCOPIC
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 east grand ave.; el segundo CA 90245
• MDR Report Key: 5909868
• MDR Text Key: 53333195
• Report Number: 5909868
• Device Sequence Number: 1
• Product Code: NKC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 20400162S
• Device Lot Number: 117891
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/19/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 61 YR
• Patient Weight: 91