MAUDE Adverse Event Report: GYRUS ACMI, INC CYSTOURETHROSCOPE STANDARD OBTURATOR, 23FR; ENDOSCOPE OBTURATOR

Model Number E123-O

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.During the evaluation, the reported issue was confirmed.During a visual inspection of the device it was observed that the tip was broken and missing.The probable cause could be due to the tip coming in contact with a hard object.No additional information has been obtained.If additional information is provided a supplemental report will be filed.The instructions manual contains several warning statements in an effort to prevent damage to the device."upon receipt, examine the instrument and accessories for damage.Do not use a damaged product.Keep the distal tip of any electrode, probe, laser fiber, or other ancillary device in the field of view at all times when active.Prior to each use, examine any electrode or other ancillary device/accessory and its insulation for damage; do not use if damaged.Examine this device prior to use.Do not use if damage is found.

Event Description

A user facility reported that the tip of the obturator scope is broken off and missing.The detached fragment was not returned with the endoscope obturator.The issue was found during reprocessing.No patient injury was reported.No additional information has been obtained.

• Brand Name: CYSTOURETHROSCOPE STANDARD OBTURATOR, 23FR
• Type of Device: ENDOSCOPE OBTURATOR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 93 north pleasant st.; norwalk, OH 44857 ; 9013785969
• MDR Report Key: 10405568
• MDR Text Key: 224590881
• Report Number: 1519132-2020-00051
• Device Sequence Number: 1
• Product Code: FEC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E123-O
• Device Lot Number: CJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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