MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PNEUMOCLEAR PLUS CO2 CONDITIONING INSUFFLATOR (AMERICAS); INSUFFLATOR, LAPAROSCOPIC

Model Number FM300

Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Dyspnea (1816)

Event Date 12/11/2019

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the patient experienced slowed heart rate resulting in the need for medical intervention to return heart rate to normal.

Manufacturer Narrative

Product was sent to oem - wom for investigation.Three attempts have been made to retrieve the oem's investigation report and it has yet to be received.In the event that the report is received, the report will be attached to the communication log.Alleged failure: patient's heart rate slowed probable root cause: because the oem's investigation report was not provided by oem - wom, probable root cause cannot be determined.The reported failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the patient experienced slowed heart rate resulting in the need for medical intervention to return heart rate to normal.

• Brand Name: PNEUMOCLEAR PLUS CO2 CONDITIONING INSUFFLATOR (AMERICAS)
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9500901
• MDR Text Key: 172224947
• Report Number: 0002936485-2019-00592
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04056702001308
• UDI-Public: 04056702001308
• Combination Product (y/n): N
• PMA/PMN Number: K170784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: FM300
• Device Catalogue Number: 0620050000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 12/11/2019
• Supplement Dates FDA Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other