MAUDE Adverse Event Report: GYRUS ACMI, INC; UNKNOWN

Model Number UNKNOWN

Device Problem Crack (1135)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The scope was not returned to olympus for evaluation.In addition, insufficient information regarding the reported event was provided by the user facility.Multiple follow-ups were made via telephone and in writing to obtain additional information but no further information was obtained.The exact cause of the reported event cannot be confirmed.However, if additional information becomes available of if the device is returned at a later date, this report will be supplemented according.

Event Description

Olympus was informed that three patients developed infections after undergoing a procedure.The cause of the patient infection is unknown according to the user facility¿s director of infection prevention.The patients were said to have been examined with a karl storz and/or olympus¿ rigid cystoscope.No serial number was provided for the resectoscope; however, olympus was informed that the subject resectoscope was sent to cdc for culturing; the result is pending.According to the user facility staff it is possible there has cracks in the device (telescope).Olympus learned that the user facility is utilizing a third-party service provided ((b)(6) medical).In addition, the olympus endoscopy support specialist stated that the user facility is manually reprocessing the scope using enzymatic detergent with 15 minute contact time and brushing.The scope then goes to an unspecified automatic scope washer (not an aer).After the instruments are dry, sterrad is used to sterilize scope.

• Type of Device: UNKNOWN
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 90017 1772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355124
• MDR Report Key: 8299543
• MDR Text Key: 134859737
• Report Number: 2951238-2019-00408
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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