MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE; LAPAROSCOPE, GYNECOLOGIC

Model Number WA50042A

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The customer reported to olympus that the video telescope "endoeye hd ii", 10 mm, 30°, autoclavable was sent in with no complaint.The device was returned for evaluation and during the evaluation the following reportable malfunction was found: the fluorescent light turns the image pink.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation, and the customer¿s allegation was confirmed.The evaluation found the following reportable issues: the image was pink.The following non-reportable malfunctions were found during the device evaluation: the housing was dented.The investigation is ongoing and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a definitive root cause of the reported event could not be identified.However, it's likely the cause is related to a defective cable unit.The cause of the defective cable unit is probably related to the following: ¿ cable pins of odu connector are too small for shield cables ¿ shield cables are grouped of up to four single cables and this shield group is too big in diameter for the pins of odu connector.Soldering joints of shield group might be too weak to withstand the forces within cable.¿ sealing compound within odu connector does not seal the soldering joints and bare cable contacts completely against steam ¿ corrosion on the soldering joints and bare cables can be seen after several autoclave cycles.¿ manufacturing jig 5016938 not fully suitable for soldering process ¿ cables and soldering joints are under stress during manufacturing process and this can lead to premature damages of the soldering joints.¿ soldering process at oste is not up to date.New guidelines for soldering process are available ¿ the new guidelines improve soldering stability and manufacturability of ¿good¿ soldering joints.¿ unacceptable tension in the area of the "ccd w.Holder" assembly due to use of an adhesive which is not adapted to the load / temperature collective and to an insufficiently formed adhesive layer "c-holder to bumper sleeve" ¿ unacceptable tension in the area of the "ccd w.Holder" assembly due to asymmetrical alignment of the spring to c-holder before the bumper sleeve is joined ¿ pre-existing damage to the "ccd w.Holder" assembly due to using a suboptimal adhesive device olympus will continue to monitor field performance for this device.

• Brand Name: VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 30°, AUTOCLAVABLE
• Type of Device: LAPAROSCOPE, GYNECOLOGIC
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18431168
• MDR Text Key: 331913260
• Report Number: 9610773-2024-00055
• Device Sequence Number: 1
• Product Code: HET
• UDI-Device Identifier: 04042761074971
• UDI-Public: 04042761074971
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA50042A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1