MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEROYAL; TUBING/TUBING WITH FILTER, INSUFFLATION, LAPAROSCOPIC

Model Number 28-0207

Device Problem Output Problem (3005)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 01/17/2022

Event Type  malfunction  

Event Description

It was found that the deroyal laparoscopic insufflation tubing with adapter does not have the same connection to confirm in the stryker pneumosure xl high-flow insufflation that a good seal is present.Thus, accurate pressure monitoring of insufflation is not able to be monitored.During procedure, stryker insufflator did not regulate to the specified pressure, increasing to the point the patient experienced respiratory issues.Procedure was aborted.

Event Description

It was found that the deroyal laparoscopic insufflation tubing with adapter does not have the same connection to confirm in the stryker pneumosure xl high-flow insufflation that a good seal is present.Thus, accurate pressure monitoring of insufflation is not able to be monitored.During procedure, stryker insufflator did not regulate to the specified pressure, increasing to the point the patient experienced respiratory issues.Procedure was aborted.Update: upon further investigation by the reporting facility, the clinical staff realized that the issue is not with the deroyal tubing, but rather the adapter that stryker has for the pneumosure insufflator.Deroyal has been informed of these new findings.

Event Description

It was found that the deroyal laparoscopic insufflation tubing with adapter does not have the same connection to confirm in the stryker pneumosure xl high-flow insufflation that a good seal is present.Thus, accurate pressure monitoring of insufflation is not able to be monitored.During procedure, stryker insufflator did not regulate to the specified pressure, increasing to the point the patient experienced respiratory issues.Procedure was aborted.Update: upon further investigation by the reporting facility, the clinical staff realized that the issue is not with the deroyal tubing, but rather the adapter that stryker has for the pneumosure insufflator.Deroyal has been informed of these new findings.

• Brand Name: DEROYAL
• Type of Device: TUBING/TUBING WITH FILTER, INSUFFLATION, LAPAROSCOPIC
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• MDR Report Key: 13415043
• MDR Text Key: 284823174
• Report Number: 13415043
• Device Sequence Number: 1
• Product Code: NKC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 28-0207
• Device Catalogue Number: 28-0207
• Device Lot Number: 54937122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20075 DA
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Race: White