Model Number JR-ST25-2.0-6 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Date 12/03/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Analysis is pending return of the device.
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Event Description
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During a left upper lobectomy on the second firing of the stapler, the surgeon stapled the bronchus of the patient.The staple line looked good at that time.Upon case completion an air leak was detected.The staple line was observed again and the surgeon noticed that two staples were intact but the rest did not form 'b" shaped staples.The bronchus was sewn shut.
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Manufacturer Narrative
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12/18/18: despite initial indication that the device would be returned and pictures provided, the customer indicated that neither were available.12/21/18: medwatch (b)(4) received with additional patient information.01/16/19: the production records for lot numbers 75jh2617 and 75kh1513 were reviewed.No anomalies were noted on the lot release paperwork.The investigation concluded that the device did not malfunction.Based on the tissue type being stapled, it is likely that the device was used on tissue outside the recommended thickness range of 0.75 - 1.0 mm.
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Event Description
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During a left upper lobectomy on the second firing of the stapler, the surgeon stapled the bronchus of the patient.The staple line looked good at that time.Upon case completion an air leak was detected.The staple line was observed again and the surgeon noticed that two staples were intact but the rest did not form 'b" shaped staples.The bronchus was sewn shut.
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Search Alerts/Recalls
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