MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PNEUMOCLEAR PLUS CO2 CONDITIONING INSUFFLATOR (GLOBAL); INSUFFLATOR, LAPAROSCOPIC

Catalog Number 0620050010

Device Problem Increase in Pressure (1491)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 08/09/2023

Event Type  Injury  

Event Description

It was reported that the patient experienced subcutaneous emphysema.

Manufacturer Narrative

Stryker is the initial importer of this product.The legal manufacturer is world of medicine (wom).Wom has been made aware of this report event.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

Manufacturer Narrative

The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: subcutaneous emphysema swelling of the skin.Probable root cause: because device was not returned to oem - wom, probable root cause cannot be determined.Most of the reasons for occurrence of a subcutaneous emphysema are related to surgical technique and trocar placement.Incorrect placement of a cannula, veress needle or a trocar into subcutaneous tissue may lead to emphysema, which can lead to crepitus.A big leakage of co2 around trocar incisions may also lead to subcutaneous emphysema.Other risk factors are prolonged surgeries, the use of many access points to the abdominal cavity and an elevated abdominal pressure.In addition, the event description does not include any indication for a device malfunction, nor is subcutaneous emphysema considered a serious injury.The reported failure mode will be monitored for future reoccurrence.Stryker is the initial importer of this product.The legal manufacturer is world of medicine (wom).Wom has been made aware of this report event.H3 other text : 81.

Event Description

It was reported that the patient experienced subcutaneous emphysema.

• Brand Name: PNEUMOCLEAR PLUS CO2 CONDITIONING INSUFFLATOR (GLOBAL)
• 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: 17687218
• MDR Text Key: 322696321
• Report Number: 0002936485-2023-00888
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04056702003456
• UDI-Public: 04056702003456
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K201361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

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: 0620050010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 08/09/2023
• Supplement Dates FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2022
• 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
• Patient Sex: Prefer Not To Disclose