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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE RENEWAL ETHICON HARMONIC ACE®+ SHEARS W/O ADAPTIVE TISSUE TECHNOLOGY 36CM

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MEDLINE RENEWAL ETHICON HARMONIC ACE®+ SHEARS W/O ADAPTIVE TISSUE TECHNOLOGY 36CM Back to Search Results
Catalog Number HAR36MRH
Device Problems Pad (900); Device Fell (4014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/18/2019
Event Type  Malfunction  
Manufacturer Narrative

It was reported that the teflon pad on the distal jaw of the reprocessed ethicon harmonic ace®+ shears, w/o adaptive tissue technology 36cm, fell off into patient's surgical site. The procedure being done is unknown. No information was provided on how the teflon pad was retrieved from the patient's surgical site. Medical intervention was reportedly required and the patient needed additional anesthesia as a result of the incident. There was no reported serious injury related to this event. Due to the reported event and medical intervention required, this medwatch is being filed. The sample was returned for evaluation and the complaint was confirmed. A potential root cause of the device failure is over-use by the end user. A definitive root cause could not be determined at this time. A review of the device history record was performed for the reported lot and this indicated that all processes were conducted as required at the time the lot was processed. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.

 
Event Description

It was reported that the teflon pad on the distal jaw of the reprocessed ethicon harmonic ace®+ shears fell off into patient/surgical site.

 
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Brand NameETHICON
Type of DeviceHARMONIC ACE®+ SHEARS W/O ADAPTIVE TISSUE TECHNOLOGY 36CM
Manufacturer (Section D)
MEDLINE RENEWAL
1500 ne hemlock ave
redmond OR 97756
Manufacturer Contact
stephen wilson
1500 ne hemlock ave
redmond, OR 97756
MDR Report Key8798050
MDR Text Key170111710
Report Number3032391-2019-00017
Device Sequence Number1
Product Code NLQ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 07/17/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberHAR36MRH
Device LOT Number415586
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/05/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2019
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/17/2019 Patient Sequence Number: 1
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