MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL HD EPSCP,4.0,30,175,CW_STORZ; RIGID ENDOSCOPE

Model Number	242008
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Poor Quality Image (1408); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: ((b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that the device "do not work anymore ".Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: distal end is damaged optic is damaged shaft bent shaft dented poor image quality.Shaft, distal tip, optics were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.The faulty parts was identified as the root cause for the device failure during the service evaluation.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.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.
Event or Problem Description
It was reported by the affiliate in (b)(6) that the hd epscp,4.0,30,175,cw_storz endoscope device did not work.During in-house engineering evaluation, it was determined that the device displayed poor quality.There was no procedure nor patient involvement reported.No additional information was provided.

• Brand Name: HD EPSCP,4.0,30,175,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 ; 8472871282
• MDR Report Key: 14073766
• Report Number: 1221934-2022-01116
• Device Sequence Number: 5948042
• Product Code: HRX
• UDI-Device Identifier: 10886705028771
• UDI-Public: 10886705028771
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign,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: 242008
• Device Catalogue Number: 242008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2017
• 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