MAUDE Adverse Event Report: STRYKER INSTRUMENTS-FREIBURG MONOPOLAR PROBE, 85MM, STRAIGHT, FLEX; STIMULATOR, ELECTRICAL, EVOKED RESPONSE

Catalog Number	5140-525-608
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Quality investigation is in progress; additional information will be submitted once the quality investigation is completed.
Event or Problem Description
The user facility reported the device didn't provide stimulation during use in a surgical procedure.This condition, in which the device does not deliver energy, may be interpreted by the user as a false negative result, or may result in the loss of ability to nerve monitor, posing increased risk of transection of a nerve.The procedure was completed successfully.There was no surgical delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.Device not returned.
Event or Problem Description
The user facility reported the device didn't provide stimulation during use in a surgical procedure.This condition, in which the device does not deliver energy, may be interpreted by the user as a false negative result, or may result in the loss of of ability to nerve monitor, posing increased risk of transection of a nerve.The procedure was completed successfully.There was no surgical delay, no medical intervention, and no adverse consequences.

• Brand Name: MONOPOLAR PROBE, 85MM, STRAIGHT, FLEX
• Common Device Name: STIMULATOR, ELECTRICAL, EVOKED RESPONSE
• Manufacturer (Section D): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; DE D-79111
• MDR Report Key: 8803696
• Report Number: 0001811755-2019-02314
• Device Sequence Number: 16228943
• Product Code: GWF
• UDI-Device Identifier: 37613327282239
• UDI-Public: 37613327282239
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K111647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2020

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 Catalogue Number: 5140-525-608
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 01/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1