MAUDE Adverse Event Report: STRYKER CORPORATION PNEUMOSURE; INSUFFLATOR, LAPAROSCOPIC

Model Number	0620040690
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
When the insufflation tubing was inserted into the stryker insufflation generator an audible air leaking was noted.The clear gas tubing was slightly ajar from the grey housing; this rn was in a case earlier where the exact noise/circumstance occurred.The remedy for both rns was to firmly insert the clear tubing further within the grey housing and that eliminated the noise.The doctor felt the insufflation was continuing even though the generator and its readings were accurate and the machine was giving too much (causing it to error/alarm).The patient became bradycardic with a heart rate of 22, gas stopped, the mda was called and pharmacological intervention was given with good result.Another insufflation generator was obtained and staff resumed the case with the non-heated version of the pneumosure.The doctor reused the prior used heated tubing with the new generator, with a good result.No lasting harm came to the patient and the procedure was completed as planned.The machine was inspected by biomed with no issues found and the tubing was sent to clinical engineering.The tubing will be returned to the manufacturer for failure analysis.Manufacturer response for insufflator, laparoscopic, pneumosure (per site reporter).The device will be returned for failure analysis.Any correspondence will be shared with medsun.

• Brand Name: PNEUMOSURE
• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER CORPORATION; 2825 airview boulevard; portage MI 49002
• MDR Report Key: 8132451
• Report Number: 8132451
• Device Sequence Number: 10797617
• Product Code: HIF
• UDI-Device Identifier: 07613327055658
• UDI-Public: (01)07613327055658
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2018
• Report Date (Section F): 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0620040690
• Device Catalogue Number: 0620-040-690
• Device Lot Number: 56006643
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 114
• Date Report Sent to FDA: 11/29/2018