MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL HD EPSCP,4.0,0,167,MITEK; RIGID ENDOSCOPE

Model Number	242017
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by the sales rep that the glass on the endoscopy device was broken.There was no procedure nor patient involvement.No additional information was provided.
Additional 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: the complaint device was sent to the supplier and evaluated.It was reported that the glass was broken in hd arthroscope/sinuscope 4.0mm x 0 deg x 167mm (mitek lock).Per service manual operational and diagnostic, this complaint can be confirmed.It was found during evaluation that the optical components inside the optical system of the endoscope were broken and the welding seam between the outer tube and the main body was broken.Further, the image on the camera was blank.Additionally, the outer tube of the endoscope was strongly bent.The whole endoscope shows minimal traces of usage (i.E.Scratches) and the distal end shows usual traces of usage (i.E.Discoloration, deposits).The device was repaired to resolve the issues.After repair, the device was found to be working according to the specifications.The broken welding seam between the outer tube and the main body, the broken optical components inside the optical system of the endoscope, the bent outer tube were caused by applying too much force on the endoscope during usage by the customer as per the manufacturer upon evaluation.Most probably the endoscope fell down or was hit by mistake.The exact circumstances that led to these damages cannot be identified.A manufacturing record evaluation was performed for the finished device serial number (b)(6), and no non-conformance was identified.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.

• Brand Name: HD EPSCP,4.0,0,167,MITEK
• Common Device Name: RIGID ENDOSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 11124951
• Report Number: 1221934-2021-00026
• Device Sequence Number: 4294119
• Product Code: HRX
• UDI-Device Identifier: 10886705029143
• UDI-Public: 10886705029143
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020

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: 242017
• Device Catalogue Number: 242017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1