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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL HD EPSCP,1.9,30,60,CW_STORZ RIGID ENDOSCOPE

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MEDOS INTERNATIONAL SàRL HD EPSCP,1.9,30,60,CW_STORZ RIGID ENDOSCOPE Back to Search Results
Model Number 242048
Device Problems Break (1069); Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/27/2020
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 and evaluated at the service center. The reported complaint that the shaft on the scope was bent, was confirmed. The following defects were found with the device upon evaluation : outer tube damaged, needle, outer tube bent, outer tube damaged, distal tip, distal tip has deposits, optical system, optical components, broken lenses in optical system. The damaged parts were replaced and the device was tested and found to be working according to specifications. User mishandling is the most probable root cause of the physical damage to the device, including the broken lenses, probably due to fall. The deposits on the distal tip can be attributed to lack of cleaning and maintenance activities on the device by the customer. There are no indications from this complaint investigation that the failures are manufacturing-related, therefore a manufacturing record evaluation is not required. At this point in time, no corrective action is required, and no further action is warranted. Depuy 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 sales rep via email that post operatively to an unknown procedure it was found that the shaft on a hd arthroscope/sinuscope, ep, 1. 9mm, 30 deg, 60mm (storz style) was bent. No surgical delay or patient consequence reported.
 
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Brand NameHD EPSCP,1.9,30,60,CW_STORZ
Type of DeviceRIGID ENDOSCOPE
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
MEDOS SARL TOLLER MITEK
chemin blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key10626955
MDR Text Key209792862
Report Number1221934-2020-02862
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 09/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number242048
Device Catalogue Number242048
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2020
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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