MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL HD EPSCP,4.0,70,167,MITEK; RIGID ENDOSCOPE

Model Number	242021
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the sales rep that the hd epscp,4.0,70,167,mitek device coupler would not focus and appeared to have a crack in it.During in-house engineering evaluation, it was determined that the distal tip had deposits and the lens was broken in the optical system on the device.There was no procedure nor patient involvement reported.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.Reporter is a j&j sales representative.The device manufacture date is currently unavailable.Investigation summary: the complaint device was received at the manufacturing site and evaluated.During the service evaluation the following defects were identified: outer tube damaged, bent/dented.Distal tip has deposits.Optical system, optical components broken lenses in optical system, cracked lens.Distal cover glass/negative damaged.Per service reports, this complaint can be confirmed.The defective parts needs to be replaced to resolve the issues.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.As part of depuy 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.Udi: (b)(4).

• Brand Name: HD EPSCP,4.0,70,167,MITEK
• Common Device Name: RIGID ENDOSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; 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 ; 6013142063
• MDR Report Key: 16612420
• Report Number: 1221934-2023-01349
• Device Sequence Number: 14729884
• Product Code: HRX
• UDI-Device Identifier: 10886705028986
• UDI-Public: 10886705028986
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 242021
• Device Catalogue Number: 242021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 03/24/2023
• 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