MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL HD EPSCP,1.9,0,60,CW_STORZ; RIGID ENDOSCOPE

Model Number	242047
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the complaint device was received at the supplier facility and evaluated.It was reported that the device was bent.Per evaluation findings, this complaint can be confirmed.It was found during evaluation that the outer tube was damaged, there was no needle, and there were broken lenses in the optical system.The issues were resolved with spare parts and the device was found to be working according to the specifications after carrying out the repair activities.Due to the replacement of parts, the serial number was changed to (b)(4).User mishandling, lack of maintenance and/or a fall from the customer can be the most probable root causes of the identified failures.The potential causes for these issues are not related to manufacturing, therefore a manufacturing record evaluation is not required.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 or Problem Description
It was reported by the employee via phone they noticed that both hd scopes were bent when they were going through a quality check.There was no case involved.

• Brand Name: HD EPSCP,1.9,0,60,CW_STORZ
• Common Device Name: RIGID ENDOSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10464710
• Report Number: 1221934-2020-02318
• Device Sequence Number: 2404169
• Product Code: HRX
• UDI-Device Identifier: 10886705028092
• UDI-Public: 10886705028092
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K080560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/25/2020

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
• Operator of Device: Health Professional
• Device Model Number: 242047
• Device Catalogue Number: 242047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 08/28/2020
• Patient Sequence Number: 1