MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL HD EPSCP,2.7,30,75,CW_STORZ; RIGID ENDOSCOPE

Model Number	242056
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
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 sales rep via email that the hd epscp,2.7,30,75,cw_storz device was broken when taken out of optics kit.The glass inside the scope itself was broken and very little light was coming through.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.H10 additional narrative: investigation summary: the complaint device was received at the service center and evaluated.It was reported that the hd arthroscope/sinuscope, ep, 2.7mm, 30 deg, 75mm (storz style) was broken already when taken out of optics kit.The glass inside the scope itself was broken and very little light was coming through.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: ¿ minor scratches on the unit ¿ bent/dented ¿ outer tube damaged, needle outer tube bent, outer tube compressed.¿ distal tip damaged, distal cover glass/negative damaged.¿ outer tube body / light post.Glass cone defective/broken.¿ laser welding damaged, needle.Welded seam cracked.¿ optical system, broken lenses in optical system less than 50% of lenses defective ¿ illumination.Fibers broken, illumination low.The defective parts were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.The user error was identified as the root cause for the device failure during the service evaluation.Old sn (b)(6) is changed to new sn (b)(6).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.Device history lot: 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.

• Brand Name: HD EPSCP,2.7,30,75,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 (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 12238377
• Report Number: 1221934-2021-02302
• Device Sequence Number: 14726728
• Product Code: HRX
• UDI-Device Identifier: 10886705028146
• UDI-Public: 10886705028146
• 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: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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: 242056
• Device Catalogue Number: 242056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 01/11/2022
• 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