MAUDE Adverse Event Report: GYRUS ACMI INC. CYSTOSCOPE; CYSTOSCOPE AND ACCESSORIES

Lot Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 09/18/2015

Event Type  Injury  

Manufacturer Narrative

The report did not provide a specific model and serial number of the cystoscope and therefore, it is unknown if the device has been returned to olympus for evaluation.The reporter does not mention a specific failure associated with the olympus cystoscope.Olympus is also unable to comment how the patient developed an infection as indicated by the voluntary event report mw5057216.The report does not provide additional information about the patient's case details.The instructions manual provides several warning statements regarding comments associated with third party repairs."olympus is not liable for any injury or damage which occurs as a result of repairs attempted by non-olympus personnel.Never repair by persons other than olympus-qualified technicians or modify the instrument, as this may result injury of the patient or operator as well as damage to the equipment.These instruments do not contain any user-serviceable parts.Do not disassemble, modify or attempt to repair; patient or user injury and/or equipment damage can result.As repair performed by persons who are not qualified by olympus could cause patient or user injury and/or equipment damage, be sure to contact olympus for repair.".

Event Description

Olympus received a voluntary event report, mw 5057216 that indicates a patient developed an infection after an unspecified procedure where a rigid cystoscope was used to examined the patient's bladder.Detailed information regarding the case, location where the procedure was performed and device information is not avaiable.

• Brand Name: CYSTOSCOPE
• Type of Device: CYSTOSCOPE AND ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI INC.; 136 turnpike road; southborough MA 01882 2104
• Manufacturer Contact: donny shapiro ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355161
• MDR Report Key: 5655438
• MDR Text Key: 45198504
• Report Number: 2951238-2016-00229
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/13/2016

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
• Device Operator: No Information
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2015
• Initial Date FDA Received: 05/13/2016
• 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