MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL HD COUPLER, C-MOUNT, 20MM; ENDOSCOPE CAMERA ADAPTOR

Model Number	242316
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the device was received and inspected visually.Upon visual inspection, it was noticed that the in the loop of the device is blurry/not clear.Its possibly due to moisture or foreign substance in it.The received device would not be serviced as the product code (242316) is in process to be obsolete.A manufacturing record evaluation was performed for part no: 242316, serial.No: (b)(4), and no non-conformances were identified.The device can not be tested for functionality but will be confirmed based on the visual inspection.No structural anomalies were observed.Based on given the information provided we cannot discern a definitive root cause for the reported failure.At this point, 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 sales rep via email that during a shoulder scope procedure the coupler, c-mount, 20 mm is cloudy.The procedure was completed with another coupler with no patient harm but there was a minute surgical delay to the case to change out the coupler.The device will be returning for evaluation.

• Brand Name: HD COUPLER, C-MOUNT, 20MM
• Common Device Name: ENDOSCOPE CAMERA ADAPTOR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9832572
• Report Number: 1221934-2020-00856
• Device Sequence Number: 19565504
• Product Code: FEM
• UDI-Device Identifier: 10886705026272
• UDI-Public: 10886705026272
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 03/13/2020

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: 242316
• Device Catalogue Number: 242316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 03/14/2020
• Patient Sequence Number: 1