MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG; PNEUMO SURE XL HIGH FLOW INSUFFLATOR W SIDNE (EU1); INSUFFLATOR, LAPAROSCOPIC

Catalog Number 0620040611

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 06/08/2017

Event Type  Death  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.(b)(4) stryker ahto tube set with tip packaging (b)(4); (b)(4) pkg., ahto irrigation pump (b)(4); 0620040611 pkg; pneumo sure xl high flow insufflator w sidne (eu1) (b)(4); (b)(4) tube set dispo with heating (b)(4).

Event Description

File for patient death during medical procedure.

Manufacturer Narrative

(b)(4).Alleged failure: problems with the patient came up during surgery.The power of the insufflator has been reduced immediately and at the end shut down.Patient could not be resuscitated.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause/s in regards to the gas connector could be that it was not properly connected and/or it was damaged during shipping.The product was returned for investigation and the failure mode was not confirmed and will be monitored for future reoccurrence.

Event Description

File for patient death during medical procedure.

• Brand Name: PKG; PNEUMO SURE XL HIGH FLOW INSUFFLATOR W SIDNE (EU1)
• 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: valerie estrada ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 6679749
• MDR Text Key: 78763782
• Report Number: 0002936485-2017-00627
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2018

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 Catalogue Number: 0620040611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2017
• Initial Date FDA Received: 06/29/2017
• Supplement Dates Manufacturer Received: 06/08/2017
• Supplement Dates FDA Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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
• Patient Outcome(s): Death
• Patient Age: 56 YR