MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG; PNEUMO SURE XL HIGH FLOW INSUFFLATOR; INSUFFLATOR, LAPAROSCOPIC

Model Number 0620040610

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Pressure Problem (3012)

Patient Problem Bradycardia (1751)

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient became bradycardic.The procedure was completed successfully.

Event Description

It was reported that the patient became bradycardic.The procedure was completed successfully.

Manufacturer Narrative

Alleged failure: cib reggie, biomed dept, having issue with unit , physition had a consuren the unit gave patient mild shock reaction when in use, bio tech could not find issue need another opinion, po 1804451.Updated information indicates that the patient heart rate dropped below 50 and they became bradycardic.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.There is no probable root cause in relation to the complaint as there were no errors or observances which occurred during the functional testing of the unit.However, given the unit is past due for calibration, preventative maintenance is recommended, as well as changing the gas adapter as the sinter filter is dirty.The product was returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.

• Brand Name: PKG; PNEUMO SURE XL HIGH FLOW INSUFFLATOR
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11149870
• MDR Text Key: 227550499
• Report Number: 0002936485-2021-00012
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 07613327063295
• UDI-Public: 07613327063295
• Combination Product (y/n): N
• PMA/PMN Number: K063367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0620040610
• Device Catalogue Number: 0620040610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 77