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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SPETZLER BARRACUDA; INSTRUMENT, ULTRASONIC SURGICAL
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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SPETZLER BARRACUDA; INSTRUMENT, ULTRASONIC SURGICAL Back to Search Results
Catalog Number 5450-800-310
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Nerve Damage (1979)
Event Date 06/15/2021
Event Type  Injury  
Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded by customer.
 
Event Description
It was reported that during a surgical procedure, the surgeon used an incorrect stryker sonopet product.It was also reported that the patients facial nerve was mistakenly cut by the surgeon.It was further reported that the procedure was completed successfully.
 
Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : device discarded by customer.
 
Event Description
It was reported that during a surgical procedure, the surgeon used an incorrect stryker sonopet product.It was also reported that the patients facial nerve was mistakenly cut by the surgeon.It was further reported that the procedure was completed successfully.
 
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Brand Name
SPETZLER BARRACUDA
Type of Device
INSTRUMENT, ULTRASONIC SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
MDR Report Key12206774
MDR Text Key262877155
Report Number3015967359-2021-01650
Device Sequence Number1
Product Code LFL
UDI-Device Identifier37613252026700
UDI-Public37613252026700
Combination Product (y/n)N
PMA/PMN Number
K020220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 09/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number5450-800-310
Was Device Available for Evaluation? No
Date Manufacturer Received09/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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