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

Catalog Number 0620040504

Device Problems Increase in Pressure (1491); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

The device manufacture date is not known at this time.However, should it become available, it will be provided in future reports.Additional information will be provided once the investigation has been completed.(b)(4).

Event Description

It was reported that the insufflator was unable to detect pressure levels and overpressurizing.There was no associated procedure in this event.

Manufacturer Narrative

Gtin: (b)(4).The device manufacture date is not known.Alleged failure: cib cus lori.Purch.Over pressurizing and showing 0 but maintaining high pressure.Po (b)(4).The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.There is no probable root cause as the unit passed the specific, functional tests for this product as per user manual 1000400737 and service guide p23979.Therefore, this unit is deemed as no problem found.The product was returned for investigation and the failure mode was not confirmed and will be monitored for future reoccurrence.

Event Description

It was reported that the insufflator was unable to detect pressure levels and overpressurizing.There was no associated procedure in this event.

• 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
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: ashley lower ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7043046
• MDR Text Key: 93198784
• Report Number: 0002936485-2017-01135
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

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: Other
• Device Catalogue Number: 0620040504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 10/25/2017
• Supplement Dates FDA Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1