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

Catalog Number	0620040600
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the device was over inflating with no alarms.Please note, the procedure was completed successfully.
Event or Problem Description
It was reported that the device was over inflating with no alarms.Please note, the procedure was completed successfully.
Additional Manufacturer Narrative
Alleged failure: cib jennifer surgery over inflating and no alarm, po# (b)(4) 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 the unit performed to specification with no errors observed as per the customer complaint.However, the unit is past due for calibration and preventative maintenance.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: PKG; PNEUMO SURE HIGH FLOW INSUFFLATOR
• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8321864
• Report Number: 0002936485-2019-00054
• Device Sequence Number: 1739689
• Product Code: HIF
• UDI-Device Identifier: 07613327063219
• UDI-Public: 07613327063219
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K063367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0620040600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1