MAUDE Adverse Event Report: GYRUS ACMI, INC SMART STAPES PISTON .6 X 4.50 MM

Model Number 70145928

Device Problem Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the service center for evaluation.Therefore, the exact cause of the reported event cannot be determined.Upon return of the device, an evaluation will be performed, and a supplemental report will be submitted.

Event Description

The service center received a report of a smart stapes piston (model 70145928), lot number sm853523, where the hook failed to crimp upon heat application.It was not reported if a new device was implanted and if the intended procedure was completed.It was reported there was no patient injury or death.

Event Description

The service center received a report of a smart stapes piston (model 70145928), lot number sm853523, whose hook failed to crimp upon heat application.The smart stapes piston was inspected prior to the procedure and no anomalies were observed.The physician was performing a therapeutic stapedotomy and the reported incident occurred towards the end of the procedure.A new smart stapes piston, from the same lot number, was used to complete the procedure.It was reported there was a delay of over twenty minutes, and there was a prolonged length in anesthesia provided to the patient.There was no patient death or injury reported from the incident.

Manufacturer Narrative

This supplemental report is being submitted to provide the initial device evaluation and additional information provided by the original equipment manufacturer (oem).The manufacture date, expiration date, and unique device identification (udi) number were provided by the oem.Udi # (b)(4).The smart stapes piston (model 70145928) lot number sm853523, was returned to the service center for the evaluation for the reported issue of the ¿hook stayed open and did not crimp upon heat application¿.The user¿s complaint could not be confirmed on the initial evaluation.A visual inspection was performed on the returned condition device; it was received in a blue plastic container, removed from the sterile packaging prior to receipt at the service center.The outer sterile packaging was not returned with the stapes piston.It was observed that foreign material was on the actual stapes piston, most notably at the distal tip.It was also observed that the hook was still open at the distal tip and not yet crimped.Additionally, it was noted that the small piece of clear covering which goes over the longer portion of the device, has a slight wear at the edges.The device was further evaluated when the stapes piston was measured with digital calipers and the following measurements were obtained; the diameter was noted to be 0.6mm and the stapes piston functional length was measured to be approximately 4.5mm.Both measurements corresponded to the measurements provided in the ent catalog.The instructions for use (ifu) states the following: "the shape-memory properties of the nitinol are designed to aid the surgeon in the crimping of the wire loops around the incus or malleus.In most cases, further crimping will not be necessary, however, the surgeon should always check the wire loops to determine if additional manual adjustment (tightening or loosening) of the crimp should be made.Following placement of the prosthesis, the ossicular chain is palpated, and the movement of the prosthesis is inspected." if desired, crimping of the loops may be initiated by exposing them to approximately 65° c.At this temperature they will begin to close to their original, unopened shape and stabilize the prosthesis.This greatly simplifies crimping.Studies have shown that this can be accomplished by any of the following ways: ¿ by the use of a low temperature (65° c) heating device.Once the loops have been placed around the incus or malleus, the low temperature heating device may be positioned so that the tip is in near proximity to the loops on the incus or malleus.At a distance of.5 mm to 1 mm, the heat generated by the low temperature heating device is sufficient to activate the closing of the wire loops.By touching the tip of a bipolar cautery to the wire loops and applying electrical energy of approximately 10 watts.Heat energy transfer occurs best when the incus or malleus is first moistened with a few drops of saline.A setting of greater than 10 watts for the bipolar cautery increases the likelihood that damage to the surrounding mucosa may occur.Based upon the information obtained in the initial evaluation, the device was forwarded to the original equipment manufacturer (oem) for additional investigation.The device was shipped overnight to the oem facility on february 12, 2020.Upon completion of the investigation, a supplemental report will be submitted.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation by the original equipment manufacturer (oem).The smart stapes piston, model 70145928, lot number sm853523 arrived at the oem in the original molded autoclavable container.No original exterior box was received.The device was received at the oem for evaluation of "hook stayed open and did not crimp when heat was applied." a visual inspection of the received condition device was performed.The smart stapes piston was received in the open position.Observation of the wire noted discoloration of the wire and material build up located at the loop end of the wire.Build up at the wire loop end is consistent with that of material melting.No other physical anomalies were noted.The received device was tested using an olympus smart thermal handle 7013-1012.Multiple attempts to activate the wire were made but unsuccessful.The user facility¿s complaint was confirmed.Per ifu (b)(4), a device producing a low temperature of 65°c or a device producing 10w is required to activate the smart piston.The olympus smart thermal handle is recommended for use with this device.Multiple attempts to contact the physician/user facility to inquire if the recommended olympus heating device was used in the procedure; no response has been received as of this date.A device history record (dhr) review was performed by the oem.The smart stapes piston was manufactured at the osta oem facility according to procedures and processes, and there were no known deviations or non-conformances reported.All finished product packaging and device inspections met specifications.Based upon the evaluation of the returned condition device, the user's reported issue was confirmed as the hook failed to crimp upon heat application.

• Brand Name: SMART STAPES PISTON .6 X 4.50 MM
• Type of Device: SMART STAPES PISTON
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 9644891
• MDR Text Key: 219118659
• Report Number: 2951238-2020-00323
• Device Sequence Number: 1
• Product Code: ETB
• Combination Product (y/n): N
• PMA/PMN Number: K003214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70145928
• Device Lot Number: SM853523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1