Catalog Number 80-1189 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Information (3190)
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Event Date 12/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Upon completion of the investigation a follow up report will be filed.
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Event Description
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Leakage was noted during preparation before the surgery with 2 complaint products.The location of hole is unknown.The device was used with cmcv.User training is done.There was no surgical delay and no adverse consequence to the patient.No further information was provided by the hospital.The products will be returned to your site.
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Manufacturer Narrative
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(b)(4).Device was returned for evaluation.A follow up report will be filed upon completion of the investigation.A review of the device history record found no discrepancies when the device was released to stock on the 21st of october 2016, expiry date 30th september 2021.
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Manufacturer Narrative
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(b)(4).Upon completion of the investigation it was noted that only one integrated tube/cord sets unitized p/n 80-1189; lot # c95551 was returned.There is a hole in the connection area/silicone-pumping segment.The hole was found in the silicone tubing and is aligned with end of the bottom connector.The actual damage is consistent with the abrasion that can occur when loading the tube set at either the upper or bottom slots of the irrigation unit.During loading of the tube sets, it is important to be aware that abrading the silicone tubing at the tube/connector transition point is possible if the tube set is loaded into the irrigation unit improperly.When loading the tubing set into the irrigation unit, the tubing should be slightly stretched so that the tube/connector transition area does not touch the slot edges.Allow then the tubing to relax into position inside the slot hole, which accepts the connector.This will minimize any abrasion of the silicone tubing during loading.A complaint of a leaking tube set from the (b)(6) market that are associated with the use of a (b)(6) only ji2000 irrigator is an anticipated issue.This risk has been evaluated and approved the (b)(6) affiliate.A review of the dhr did not show any anomalies during the manufacturing process.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.
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Search Alerts/Recalls
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