Model Number M00562531 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The exact date of the event is unknown.The provided event date of (b)(6) 2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.The initial reporter's address is (b)(6).This event was reported by the distributor.The reported physician and healthcare facility are: (b)(6).(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that a profile extra small oval flexible snare was inspected before delivery to the customer performed on an unknown date.It was reported that something that looked like an eyelashes was found inside the unopened sterile pouch.Reportedly, this was found before delivery to the customer and there was no patient involvement.
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Event Description
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It was reported to boston scientific corporation that a profile extra small oval flexible snare was inspected before delivery to the customer performed on an unknown date.It was reported that something that looked like an eyelashes was found inside the unopened sterile pouch.Reportedly, this was found before delivery to the customer and there was no patient involvement.
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Manufacturer Narrative
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Block b3: the exact date of the event is unknown.The provided event date of (b)(6), 2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block e1: the initial reporter's address is (b)(6) block e1: this event was reported by the distributor.The reported physician and healthcare facility are: (b)(6)block h6: problem code a180104 captures the reportable event of foreign material present on device.Block h10: investigation results a profile extra small oval flexible snare was received for analysis.Visual, microscopic and media inspection of the returned device revealed that a hair was found inside the original and unopened pouch.No other problems were noted.The device was returned for analysis and a hair was found inside the original sealed device pouch, confirming the reported event.An investigation was initiated to determine the cause of this event.It was found that this is an isolated incident, and it is possible that the cause could be due to an oversight on the production line and/or conditions of the clean room.There are processes in place during the manufacturing process to inspect and confirm that sealed pouches do not contain particulate or foreign matter.Although a definitive root cause was unable to be determined, since the product was returned sealed with the hair inside the pouch, the most probable cause of the event is a manufacturing deficiency.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
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Search Alerts/Recalls
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