MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PNEUMO SURE F114 INSFFLATOR SIDNE; INSUFFLATOR, LAPAROSCOPIC

Catalog Number 0620-040-604

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Activation Problem (4042)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/09/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the procedure was converted to open surgery.

Manufacturer Narrative

This device was received at oem-wom for evaluation.Based on the oem-wom investigation report attached, the reported failure ¿device did not work ¿ was not confirmed.According to wom: problem description: there was a big noise from the device and it stopped functioning.The service rep checked the device but could not fix the problem.The procedure was switched to open surgery.Wom analysis: our service technician evaluated the device but could not replicate the reported event.However it can be assumed the pressure valves inside may have some problems.Also he found the gas remaining display had a problem (it showed empty even the gas tank is full, it occurred twice during the running test of 25 hours).So the bam board might have a problem.Please also check it.Lpu defective.Hpu leakage.Manufacture date is not known.

Event Description

It was reported that the procedure was converted to open surgery.

• Brand Name: PNEUMO SURE F114 INSFFLATOR SIDNE
• 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: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15475962
• MDR Text Key: 300564722
• Report Number: 0002936485-2022-00530
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/06/2022

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: 0620-040-604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 09/24/2022
• Supplement Dates Manufacturer Received: 08/09/2019
• Supplement Dates FDA Received: 10/06/2022
• 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
• Patient Outcome(s): Other