MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SECTO; CHERRY DISSECTOR

Catalog Number 81-1002

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

During use, pieces of the cherry dissesector are coming off and it is falling apart and leaving pieces in the surgery site.There has been no harm to the patient.

Manufacturer Narrative

The actual device that experienced the problem was not available for return.The customer returned the remainder of the box from the same lot number.Picture were not provided of the incident.Upon receiving the returned devices, the devices were reviewed and sent to the manufacturing location for further review and evaluation.This is the first complaint recorded for this occurrence with (b)(4) cherry dissectors sold of all lots.A follow up report will be submitted once the manufacturing facility has completed the evaluation report.

Manufacturer Narrative

1 box of 81-1002 lot# 21k3348 was returned for evaluation.A sampling of the box was reviewed upon arrival in nashville 3/8/2023.While the cotton dissector did not fall apart easily, it was confirmed that at least one of the devices evaluated, had very small strands of cotton sticking out that were not tightly wound.Once these strands were pulled them came off the dissector gauze and they began to fall apart.The remainder of the box was sent to our supplier carwild for further evaluation 3/10/2023.Our supplier sent the returned devices to the contract manufacturing facility to conduct the investigation.We stayed in contact with the supplier throughout their investigation and provided any additional information that was requested.The complaint investigation report was received from the supplier on 6/7/2023.The supplier states the following in attached complaint closure letter; a review of the material history records and quality customer specification and it was confirmed that the product did not sufficient solution added to keep from and prevent from falling apart.The root cause of the observed condition can be attributed to the fact that the machine was becoming clogged by the solution.There are not remaining items in inventory from the lot number involved.This is an isolated event with no further containment actions required.Corrective actions: the customer was provided a replacement with a different lot number and have confirmed that they have not experienced any additional problems.Maintenance cleaned the machine and further test samples were produced to confirm that the product was receiving adequate binding solution.Preventative actions: the correct sequence for ignition initiation label was added to the machine.The machine in question was added to the weekly pm maintenance to prevent this from occurring in the future.Verification of effectiveness is not necessary per the risk assessment.We will continue to track and trend for any future occurrences.Based on the above information, no further actions are required and this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or additional informaiton pertinent to the investigation, a subsequent follow up report will be submitted.

• Brand Name: SECTO
• Type of Device: CHERRY DISSECTOR
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 16592283
• MDR Text Key: 312300186
• Report Number: 3007208013-2023-00010
• Device Sequence Number: 1
• Product Code: GDY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 81-1002
• Device Lot Number: 21K3348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1