CONSOLIDATED MEDICAL EQUIPMENT COMPANY DISPOSABLE MARKED SPRING TIP GUIDEWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
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Catalog Number DIS150 |
Device Problem
Break (1069)
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Patient Problem
Laceration(s) (1946)
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Event Date 10/28/2021 |
Event Type
Injury
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Event Description
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The customer reported issues with the disposable marked springtip guidewire, item # dis150, lot 202106115, recently experienced by (b)(6) hospital, rogers, ar on (b)(6) 2021.Information received was that during a gi endoscopy procedure, the spring tip guidewire broke and took a portion of the lining in a patient¿s stomach.It is noted the patient is fine / there was no patient injury.The procedure was completed with a delay.Clarification received notes the guidewire was having the savary dilator slide over it, when it ¿took a portion of the lining in a patient¿s stomach¿.A piece of tissue was caught up in the broken spring tip and ripped off as the guidewire was removed.A hemoclip was placed to close the tear in the stomach lining.A savary dilator with an olympus 190 gastrocope were also being used at the time.This report is being raised on the basis of injury as it is noted a piece of the patient¿s tissue was caught in the device and torn away.
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Manufacturer Narrative
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At time of filing, although expected, the reported device has not been received into conmed¿s complaint system for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
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Event Description
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The customer reported issues with the disposable marked springtip guidewire, item # dis150, lot 202106115, recently experienced by (b)(6) hospital, (b)(6) on (b)(6) 2021.Information received was that during a gi endoscopy procedure, the spring tip guidewire broke and took a portion of the lining in a patient¿s stomach.It is noted the patient is fine / there was no patient injury.The procedure was completed with a delay.Clarification received notes the guidewire was having the savary dilator slide over it, when it ¿took a portion of the lining in a patient¿s stomach¿.A piece of tissue was caught up in the broken spring tip and ripped off as the guidewire was removed.A hemoclip was placed to close the tear in the stomach lining.A savary dilator with an olympus 190 gastroscope were also being used at the time.This report is being raised on the basis of injury as it is noted a piece of the patient¿s tissue was caught in the device and torn away.
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Manufacturer Narrative
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Investigation of the customer's complaint of the guidewire tip breaking off is confirmed.Conmed received one dis150 in opened original packaging.The lot number was verified against documents returned with the device.A visual inspection was performed.The spring at the tip of the guidewire is broken but not detached; evaluation photographs show the spring tip was bent.A piece of the stomach tissue was returned with the device.The returned device exhibits the reported claim, nevertheless a root cause cannot be established.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Also, per the ifu, the user is advised that the guidewire should not be advanced if resistance is met without determining the cause and taking remedial action.Before and after each use, carefully inspect the guidewire for wear, damage or abnormal bending.The entire wire should be inspected in this manner, but areas of extra focus include the flexible spring tip and the soldered joints between the spring tip and wire.If the joints appear discolored, loose or cracked, discard the guidewire.If wear, damage or abnormal bending is found at any location on the guidewire, discard the guidewire.This issue will continue to be monitored through the complaint system to assure patient safety.
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