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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL HD EPSCP,4.0,30,167,MITEK RIGID ENDOSCOPE

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MEDOS INTERNATIONAL SàRL HD EPSCP,4.0,30,167,MITEK RIGID ENDOSCOPE Back to Search Results
Catalog Number 242018
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/21/2019
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Investigation summary: the device was received at service center and evaluated. The complaint can be confirmed. As per the service report outer tube damaged, distal tip damaged, shaver damage to distal tip, distal tip has deposits -optical system, broken lenses in optical system. The root cause for the reported failure could be user mishandling. However,definitive root cause cannot be determined. A manufacturing record evaluation was performed for the finished device product (242018) and lot number ((b)(4)), and no non-conformances were identified. At this point in 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. Udi: (b)(4).
 
Event Description
It was reported by the sales rep via phone that the hd epscp,4. 0,30,167,mitek had a burnt tip. They continued the case with the scope with no patient harm or delay.
 
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Brand NameHD EPSCP,4.0,30,167,MITEK
Type of DeviceRIGID ENDOSCOPE
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key8786362
MDR Text Key151103711
Report Number1221934-2019-57632
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial
Report Date 07/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/12/2019
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number242018
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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