The device was returned to the manufacturer for evaluation and the customer¿s complaint was confirmed.The a-rubber was found to have multiple leaks.On removal of the bending section cover (a-rubber) from the bending section, the service technician noted multiple bending support pins were detached, which produced sharp edges that ruptured the a-rubber.This type of physical damage is attributed to mishandling.A review of the device history record found no issues that could have caused or contributed to the reported issues.The ifu includes the following information regarding inspection of the endoscope: ¿inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.¿ in addition, the ifu warns, ¿do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, or control section.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, or light guide cable with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.¿ this mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.
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