MAUDE Adverse Event Report: GYRUS ACMI, INC OBS 12/28/01 - 30 MAGII TELESCOPE; RIGID CYSTOSCOPE, 30DEG

Model Number M2-30

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 reported device has been obsolete for 16+ years.Furthermore, the customer utilizes a third party for repair; therefore, the scope has most likely been altered and repaired.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)(4)).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.1 of 3.

Manufacturer Narrative

This supplemental report is being submitted to update section g5 with the 510k number.

• Brand Name: OBS 12/28/01 - 30 MAGII TELESCOPE
• Type of Device: RIGID CYSTOSCOPE, 30DEG
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 90017 1772
• MDR Report Key: 8299541
• MDR Text Key: 134858549
• Report Number: 2951238-2019-00406
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

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: M2-30
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: KARL STORZ RESECTOSCOPE DEVICES- MD/SN UNKNOWN
• Patient Outcome(s): Other