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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 1392 5.9MM STRYKER SHEATH 2 WAY -NS; RIGID ENDOSCOPE SHEATH

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1392 5.9MM STRYKER SHEATH 2 WAY -NS; RIGID ENDOSCOPE SHEATH Back to Search Results
Model Number 281392
Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2018
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Investigation summary: after multiple attempts to retrieve device return information, no information was provided, therefore device will not be available for a physical evaluation.This complaint is not confirmed.It was reported that the device was leaking due to damage o-rings.No further information regarding the procedure or the device used has been provided to determine a root cause for this failure.At this point in time, no corrective action is required, and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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.This report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
 
Event Description
It was reported by the sales rep via phone that during a knee arthroscopy procedure the customer's 5.9mm stryker sheath 2-way is leaking due to damaged o-rings.The procedure was able to be completed with the device with no harm to the patient or delays to the case.The sales rep was not present for the case therefore could not any further information.There was no delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
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.Investigation summary : according to the information received, it was reported that during a knee arthroscopy procedure the customer's 5.9mm stryker sheath 2-way is leaking due to damaged o-rings.The procedure was able to be completed with the device with no harm to the patient or delays to the case.After multiple attempts to retrieve device return information, no information was provided, therefore device will not be available for a physical evaluation.This complaint is not confirmed.It was reported that the device was leaking due to damage o-rings.No further information regarding the procedure or the device used has been provided to determine a root cause for this failure.According to attached memo referencing to sopro-comeg, as sopro-comeg gmbh maintained all manufacturing records in their files and no relation has been held with this company since september 2017, no manufacturing record evaluation can be performed for all lots manufactured by sopro-comeg gmbh.At this point in time, no corrective action is required, and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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
1392 5.9MM STRYKER SHEATH 2 WAY -NS
Type of Device
RIGID ENDOSCOPE SHEATH
MDR Report Key9117792
MDR Text Key207530444
Report Number1221934-2019-58506
Device Sequence Number1
Product Code HNX
UDI-Device Identifier10886705016099
UDI-Public10886705016099
Combination Product (y/n)N
PMA/PMN Number
K951702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 07/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number281392
Device Catalogue Number281392
Was Device Available for Evaluation? No
Date Manufacturer Received07/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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