MAUDE Adverse Event Report: KARL STORZ SE CO. KG ENDOMAT; ENDOSCOPIC IRRIGATION/SUCTION SYSTEM

Model Number 20330320-1

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Markings/Labelling Problem (2911)

Patient Problems Urinary Retention (2119); Abdominal Distention (2601)

Event Date 10/04/2019

Event Type  malfunction  

Event Description

Procedure began without use of continuous pump, fluid was periodically emptied from bladder into the suction canister.Approximately 2/3 of the way into the procedure the continuous pump was hooked up but not without some difficulty with the clamp on the machine.Surgeon continued to have difficulty with visualization in the field and determined that the tubing had been placed incorrectly into the pump resulting in fluid from the canister being pumped into the patient's bladder causing over-distension, increased pressure, and fluid retention.Staff report pump not clearly marked for proper tubing placement, small markings, only slightly different sized tubing.Since event, inflow and outflow have been clearly labeled and a diagram placed on top of the machine by staff.

• Brand Name: ENDOMAT
• Type of Device: ENDOSCOPIC IRRIGATION/SUCTION SYSTEM
• Manufacturer (Section D): KARL STORZ SE CO. KG; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 9266030
• MDR Text Key: 164627443
• Report Number: 9266030
• Device Sequence Number: 1
• Product Code: OCX
• 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
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20330320-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/21/2019
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28835 DA