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

Catalog Number	5140-525-608
Medical Device Problem Codes	No Display/Image (1183); Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2019
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 nerve injury.The procedure was completed successfully, without the use of nerve monitoring.There was no surgical delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.H3 other text : product not available.
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 nerve injury.The procedure was completed successfully, without the use of nerve monitoring.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: 8804333
• Report Number: 0001811755-2019-02317
• Device Sequence Number: 327201
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2020

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: 02/10/2020
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 02/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1