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

Model Number	242048
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
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 bent lens while in-servicing not during a case.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: outer tube damaged, needle.Outer tube bent.Outer tube compressed.Outer tube damaged, distal tip.Distal tip damaged.Laser welding damaged, needle welded seam cracked.Illumination.Fibers broken, illumination low.Optical system, optical components.Broken lenses in optical system less than 50% of lenses defective.Minor scratches on the unit.The defective parts 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 sales rep t during an unknown surgery on an unknown date, it was observed that the device was.During in-house engineering evaluation, it was determined that fibers broken, illumination low.Optical system, optical components.Broken lenses in optical system less than 50% of lenses defective.There were no adverse patient consequences reported.No additional information was provided.As reported by the sales rep via email, "no patient consequences for this complaint.Bent lens while in-servicing not during a case" that is all the information provided.

• 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
• MDR Report Key: 11855426
• Report Number: 1221934-2021-01590
• Device Sequence Number: 19837876
• Product Code: HRX
• UDI-Device Identifier: 10886705028108
• UDI-Public: 10886705028108
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2021

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: 03/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1