MAUDE Adverse Event Report: CHECKPOINT SURGICAL CHECKPOINT STIMULATOR; SURGICAL NERVE STIMULATOR/LOCATOR

Model Number	9094
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After further investigation, the original medwatch filing by the biomedical engineer was inaccurate based on the design specification of a single-use device, and the actual deficiency was that the hcp had difficulty locating the nerve.Based on our testing, the stimulator was found to function as specified, and the log indicated the stimulator operated as specified.There was insufficient evidence provided by the hospital to evaluate the actual deficiency, and a specific use error cannot be determined.
Event or Problem Description
Medwatch report (b)(4) received from (b)(6) hospital on (b)(6) 2021 stating: "probe is supposed to detect the nerve during surgery.Confirmed that device did not turn on." further follow-up with the institution determined the device was used in a surgery and the health care provider (hcp) had difficulty locating the nerve and was unsure if the device was operating correctly.A second hcp assisted and found the nerve had been injured.

• Brand Name: CHECKPOINT STIMULATOR
• Common Device Name: SURGICAL NERVE STIMULATOR/LOCATOR
• Manufacturer (Section D): CHECKPOINT SURGICAL; 6050 oak tree blvd; suite 360; independence OH 44131
• Manufacturer (Section G): ROBLING MEDICAL INC.; 90 weathers st; youngsville NC 27596
• Manufacturer Contact: matthew hildebrand ; 6050 oak tree blvd.; suite 360; independence, OH 44131 ; 2163789107
• MDR Report Key: 12924972
• Report Number: 3012222873-2021-00004
• Device Sequence Number: 4907100
• Product Code: ETN
• UDI-Device Identifier: B13090941
• UDI-Public: B13090941
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K092292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2022
• Device Model Number: 9094
• Device Catalogue Number: 9094
• Device Lot Number: 0310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown