MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TRAY 21, COLLAR INSTRUMENTS

Model Number	001-03-00021
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause for this malfunction was found to be related to the design and manufacture of the trays within this lot coupled with mishandling of nonconforming product by onkos.The tray bracket, which is designed and manufactured by phillips precision medicraft, was designed based on the nominal dimension of the instrument shaft where the instrument interfaces with the bracket.Variability and lack of validation of the coating process, which is performed by a supplier of precision medicraft, also contributed to this issue as the coating was thicker than what was originally accounted for when medicraft designed the bracket.However, these issues were identified prior to releasing trays to the field during final product checklist activities at onkos.The final product checklist trays and an additional tray were at onkos for training and were found to not fit pl-plane-03n correctly.These trays were mishandled as they were never marked as nonconforming via a quarantine ticket, and they were sent back to (b)(4) without identifying them as nonconforming.The trays were placed into fg and one was sent into the field causing this complaint.The instrument (pl-plane-03n is not suspected to be a contributor to this complaint as the feature is inspected and the bracket of the trays has been found to be too small to interface with the instrument when the instrument is within it specification.
Event or Problem Description
An onkos representative was performing a training of sales representatives on the use of instruments in tray 21.When he attempted to remove pl-plane-03n, it was difficult to remove as the bracket was tight around the shaft of the instrument.He was able to remove the instrument but sustained a laceration on his hand due to striking the cutting surface of one of the adjacent instruments in the tray.He did not seek further medical care after the injury.There have currently been no reports of further complications or long-term harms that have occurred from the injury.As this issue occurred during training, no patient was affected by this issue.

• Brand Name: ELEOS
• Common Device Name: TRAY 21, COLLAR INSTRUMENTS
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 12526178
• Report Number: 3013450937-2021-00219
• Device Sequence Number: 4459921
• Product Code: FSM
• UDI-Device Identifier: B27800103000210
• UDI-Public: B27800103000210
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K203815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 001-03-00021
• Device Catalogue Number: 001-03-00021
• Device Lot Number: P2100052
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1