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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US I/O FLOW SHEATH-S&N; RIGID ENDOSCOPE SHEATH
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DEPUY MITEK LLC US I/O FLOW SHEATH-S&N; RIGID ENDOSCOPE SHEATH Back to Search Results
Model Number 218019
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/07/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint#: (b)(4).Udi: (b)(4).
 
Event Description
It was reported by the sales rep via phone that the o-rings of the inflow/outflow sheath system keeps coming off.No procedure was involved at the time of the failure.The devices are available to be returned for evaluation.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: d10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary:the device was returned and inspected.Upon visual inspection, there were no physical damage was noticed.The device was disassembled, all red o-rings were found to be on their placed.The complete functional testing cannot be performed since whole system setup is not available.The complaint cannot be replicated/confirmed for the fell apart reported condition.A manufacturing record evaluation was performed for the finished device [151001] number, and no non-conformances were identified.Based on given the information provided we cannot discern a definitive root cause for the reported failure.At this time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
 
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Brand Name
I/O FLOW SHEATH-S&N
Type of Device
RIGID ENDOSCOPE SHEATH
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key10311766
MDR Text Key199988100
Report Number1221934-2020-01873
Device Sequence Number1
Product Code NBH
UDI-Device Identifier10886705023721
UDI-Public10886705023721
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup,Followup
Report Date 07/07/2020
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
Device Operator Health Professional
Device Model Number218019
Device Catalogue Number218019
Device Lot Number151001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2020
Initial Date Manufacturer Received 07/07/2020
Initial Date FDA Received07/22/2020
Supplement Dates Manufacturer Received07/30/2020
08/11/2020
Supplement Dates FDA Received07/31/2020
08/12/2020
Patient Sequence Number1
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