MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY RHOTON; DISSECTOR

Catalog Number 80-1691

Device Problem Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The customer alleged that the 80-1691 dissector broke off and fell into the patient.They were able to fish it out with no further harm to the patient.

Manufacturer Narrative

It is unknown when the device was purchased as there is no history of the customer purchasing this device in our current system that has been in place since 2012.We have not received the device back or received pictures to confirm the lot number and age of the device.It is unknown if the device is able to be returned.We will continue to attempt in gathering additional information for further investigation.There has been a total of (b)(4) sold of all lots with no additional complaint recorded for this occurrence.A follow up report will be submitted once additional information is available.

Manufacturer Narrative

After multiple attempts, no further information was received regarding this complaint investigation.There is no history of the device purchase in our erp system.This indicates that the device was purchased prior to december 2012.The customer will be purchasing new instruments to replace the device that broke.A true root cause could not be determined as the device was not returned for evaluation.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or additional information pertinent to the investigation, a follow up report will be sumbitted.

• Brand Name: SYMMETRY RHOTON
• Type of Device: 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: 16770170
• MDR Text Key: 313751116
• Report Number: 3007208013-2023-00017
• Device Sequence Number: 1
• Product Code: GZX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 80-1691
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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