MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 40L CORE SIDNE READY INSUFFLATOR; INSUFFLATOR, LAPAROSCOPIC

Catalog Number 0620040504

Device Problems Device Dislodged or Dislocated (2923); Infusion or Flow Problem (2964)

Patient Problems Cardiopulmonary Arrest (1765); Respiratory Arrest (4461)

Event Date 12/02/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient coded.The patient was recovered and surgery aborted.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: possibly faulty or misuse of an insufflator.Probable root cause: pressure sensor malfunction / out of calibration, software malfunction, use error, system design, unwanted movement of internal components / wiring, pressure button does not disengage, electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge, venting valve system or overpressure alarm failure, safety valve or regulator malfunction, hpu or lpu assembly malfunction, ppv failure, manufacturing/ service error.The reported failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the patient coded.The patient was recovered and surgery aborted.

• Brand Name: PKG, 40L CORE SIDNE READY INSUFFLATOR
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11167324
• MDR Text Key: 226762954
• Report Number: 0002936485-2021-00025
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K063367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0620040504
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other