MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH/STRYKER ENDOSCOPY HIGH-FLOW TUBE SET; INSUFFLATOR, LAPAROSCOPIC

Model Number 0620050100

Device Problems Energy Output Problem (1431); Infusion or Flow Problem (2964); Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2022

Event Type  malfunction  

Event Description

During the procedure, a laparoscopic cholecystectomy, the stryker tower lost insufflation.The instruments were immediately removed from the abdomen as the abdomen lost pressure.The insufflation tube was changed.The co2 tank was changed.Stryker rep garrett was informed via phone.Issue resolved after tubing change.Potential faulty tubing?.

• Brand Name: HIGH-FLOW TUBE SET
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH/STRYKER ENDOSCOPY; 4531 36th street; orlando FL 32811
• MDR Report Key: 15515451
• MDR Text Key: 300899945
• Report Number: 15515451
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0620050100
• Device Catalogue Number: 0620050100
• Device Lot Number: 4019360
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2022
• Date Report to Manufacturer: 09/30/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16060 DA