MAUDE Adverse Event Report: KARL STORZ ENDOVISION CONTINUOUS FLOW PUMP

Model Number	27224P
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	10/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer returned the flow pump for service on (b)(6) 2017 and there was no mention of an mdr associated with this unit.Later, we received an mdr from the customer on (b)(6) 2017.Our service dept.Found that plexiglass plate is broken on the pump head.The plexiglass plate shows the direction of flow.The flow mechanism is running in the proper direction.The cord wrap has a bend.The physical damage to the pump did not and cannot affect the performance of the pump.
Event or Problem Description
Allegedly, during a turp procedure, while karl storz continuous flow pump was used, the user experienced problems with the flow connection for the resectoscope.They claimed that "pressure was introduced from the tubing rather than withdrawn from the scope.The bladder appeared taught ( tough? ) to the surgeon.The tubing was tightened and fluid started draining out.The problem was corrected, and procedure was completed.The patient had post op abdominal pain.Cat scan revealed a perforated bladder.".

• Brand Name: CONTINUOUS FLOW PUMP
• Common Device Name: FLOW PUMP
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• MDR Report Key: 7047457
• Report Number: 1221826-2017-00093
• Device Sequence Number: 11032738
• Product Code: OCX
• UDI-Device Identifier: 04048551366837
• UDI-Public: 4048551366837
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K832009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/20/2017

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?: No
• Operator of Device: Physician
• Device Model Number: 27224P
• Device Catalogue Number: 27224P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Weight: 102