MAUDE Adverse Event Report: GYRUS ACMI, INC CF RESECTOSCOPE INNER SHEATH, 25FR; RESECTOSCOPE, INNER SHEATH

Model Number EIS-HCF25

Device Problem Break (1069)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/12/2020

Event Type  malfunction  

Manufacturer Narrative

The referenced resectoscope inner sheath was returned to the service center for evaluation of the reported event.The evaluation found that a portion of the black colored tip at the distal end of the sheath was cracked and a missing.There were no other damages noted and the passage and locking mechanism functioned appropriately.As part of the investigation, olympus followed up with the user facility to obtain additional information.The user facility further reported that all of the pieces were retrieved using a grasper.The procedure was completed using another sheath.No additional medical or surgical intervention was required.The case was delayed by a few minutes; caused the patient to be under general anesthesia for a few minutes longer.There was no damage or abnormalities noted prior to procedure when inspecting the device.The cause of the reported event cannot be determined at this time as the investigation is ongoing, however, if additional information becomes available this report will be supplemented accordingly.

Event Description

The service center was informed that during a therapeutic procedure, the black colored tip at the distal end of the resectoscope inner sheath cracked and fell off into the patient's bladder.The user was able to retrieve the broken pieces.There was no patient injury reported.

Manufacturer Narrative

This report is being submitted to provide a correction as the report information was submitted on two medical device reports in error (1519132-2020-00026 and 1519132-2020-00028).Reference mdr# 1519132-2020-00028 for all investigation details.

• Brand Name: CF RESECTOSCOPE INNER SHEATH, 25FR
• Type of Device: RESECTOSCOPE, INNER SHEATH
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10257935
• MDR Text Key: 217442018
• Report Number: 1519132-2020-00026
• Device Sequence Number: 1
• Product Code: HIH
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EIS-HCF25
• Device Lot Number: RXEB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1