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

Model Number	242048
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by sales rep that a hd arthroscope/sinuscope, ep, 1.9mm, 30 deg, 60mm (storz style) device was cracked.During in-house engineering evaluation, it was determined that the outer tube damaged, bent/dented, distal tip was damaged, distal tip fiber damaged, the compact objective was loose, the lenses were broken in the optical system and less than 50% of lenses were defective.There was no procedure nor patient involvement reported.No additional information was provided.
Additional Manufacturer Narrative
Additional narrative: udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.During the service evaluation the following defects were identified: outer tube damaged -bent/dented, outer tube damaged, distal tip damaged, distal tip fiber damaged, optical system, optical components compact objective loose, broken lenses in optical system, less than 50% of lenses defective.Per service reports, this complaint can be confirmed.The defective parts needs to be replaced to resolve the issues.As part of mitek's quality process all devices are manufactured, inspected, and released to approved specifications.The faulty parts was identified as the root cause for the device failure during the service evaluation.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.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,1.9,30,60,CW_STORZ
• Common Device Name: RIGID ENDOSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle CH-24-00 ; SZ CH-2400 ; 3035526892
• MDR Report Key: 14454822
• Report Number: 1221934-2022-01464
• Device Sequence Number: 6354738
• Product Code: HRX
• UDI-Device Identifier: 10886705028108
• UDI-Public: 10886705028108
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2022

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: 242048
• Device Catalogue Number: 242048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown