MAUDE Adverse Event Report: GYRUS ACMI, INC ROTATING CF RESECTOSCOPE INNER SHEATH

Model Number ERIS-CF25

Device Problems Break (1069); Device Fell (4014)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during an unspecified procedure, the distal tip of the device fell off into the patient.The distal tip according to the reporter was retrieved.No further details or information was provided.There was no patient impact or harm was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the device return evaluation, review of the device history records (dhr), please see updated sections: d10,g4, g7, h2, h3,h4, h6 and h10.Device visual inspection on the received condition was performed and found the ceramic insulation tip broken at the distal end side, large portion of the insulation tip (approximately 70%) was found broken.The missing piece(s) were not returned for evaluation.Additionally, an indentation near the middle of the sheath was observed.The labeling/identification was found faded.The movement from the release button was observed normal.There were no issues with resectoscope when inserted into the outer sheath.Based on the evaluation, the likely cause of the damaged ceramic insulation tip is due to mishandling.The indentation near the middle of the sheath would substantiate the claim of mishandling which possibly occurred during improper insertion or removal of the inner sheath, to the outer sheath.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Per the user¿s manual, always keep sheaths parallel to one another when assembling and disassembling.If the inner sheath is inserted or removed at an angle to the outer sheath, the lateral force applied to the inner sheath may crack, loosen, break, or otherwise damage the sheath¿s insulated distal tip.A broken tip, or fragments of a damaged tip, can potentially pass through the outer sheath and into the patient.If drag or resistance is encountered during assembly or disassembly, stop align working element and sheath parallel to one another before proceeding." olympus will continue to monitor complaints for this device.

Manufacturer Narrative

Upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

Manufacturer Narrative

Follow up report 001 ref natus complaint# (b)(4).Install date: 25 feb 2013.Repair notes: -ato replaced part no 8-35-33800 sn (b)(6).-unit fully tested at functional test.-auto calibration done.-final test passed.-visually inspected.-usb dongle replaced.Failure confirmed: yes.Problem code: main board defective.Closure rationale: complaint verified, being tracked as a trend.The current risk file 1081 aurical aud & madsen a450 - risk analysis - (b)(4) rev 04.Hazard id 5.16 identifies this issue.Harm - delay in use of the system or treatment.Cause- system looses connection with otosuite/pc due to a hardware failure.Severity- negligible (0).Risk level- minor (0).A risk review is not required as this complaint does not describe a new failure mode or new harm and the existing hazard severity and/or probability of occurrence has not changed.Capa004844 was opened to address this failure mode.Based on the risk evaluation which determined the overall risk to be minor and the age of the associated devices which has shown to be beyond the specified product lifetime of the aurical aud device, it was recommended that the capa was closed with no corrective/preventive actions.Complaints with similar symptom/failure mode will be monitored and processed as per (b)(4) complaint handling procedure.Recommended actions: no recommended actions now.If a major redesign of the device hardware done in the future, it is recommended to replace the present isolated voltage regulators, u17 and u20 with a type with lower idle power consumption.

• Brand Name: ROTATING CF RESECTOSCOPE INNER SHEATH
• Type of Device: RESECTOSCOPE
• 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: 10278072
• MDR Text Key: 208335368
• Report Number: 1519132-2020-00031
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ERIS-CF25
• Device Lot Number: AC20086533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2019
• 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