BOSTON SCIENTIFIC - COSTA RICA (COYOL) INJECTION GOLD PROBE¿; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Model Number M00560150 |
Device Problem
Material Separation (1562)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/03/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure 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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Note: this report pertains to one of two devices used during a procedure.Refer to the manufacturer report # 3005099803-2015-03719 for the first injection gold probe and manufacturer report # 3005099803-2015-03720 for the second injection gold probe.It was reported to boston scientific corporation that two injection gold probes were used in the patient's colon during a colonoscopy procedure performed on (b)(6) 2015.According to the complainant, during the procedure, the first injection gold probe was removed from the patient and the scope for cleaning.During cleaning, it was found that the distal tip of the device was got separated and was missing.A second injection gold probe was used; however, during the procedure, a part of the distal tip of the probe had detached inside the patient.Reportedly, the patient was sent for x-ray and the missing tip was found in the patient's duodenum.The procedure was completed with another injection gold probe.Despite numerous attempts boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event.Should additional relevant details become available a supplemental report will be submitted.
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Manufacturer Narrative
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Visual analysis of the returned injection gold probe¿ revealed that the ceramic distal tip was detached and was returned attached to the guide tube.Further evaluation found the catheter kinked near to the electrical connector and in the middle of the device near to proximal section and near to the distal section.Additionally, the guide tube near the distal tip was also kinked.A transversal cut applied to the catheter revealed tread marks and the device has presence of glue.The complaint was confirmed.The investigation concluded that this complaint is associated with a product that meets design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.Therefore, the most probable root cause classification for the reported failure is operational context.A review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no other complaints exist for the specified lot.
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Event Description
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Note: this report pertains to one of two devices used during a procedure.Refer to the manufacturer report # 3005099803-2015-03719 for the first injection gold probe¿ and manufacturer report # 3005099803-2015-03720 for the second injection gold probe¿.It was reported to boston scientific corporation that two injection gold probes were used in the patient¿s colon during a colonoscopy procedure performed on (b)(6) 2015.According to the complainant, during the procedure, the first injection gold probe was removed from the patient and the scope for cleaning.During cleaning, it was found that the distal tip of the device was got separated and was missing.A second injection gold probe was used; however, during the procedure, a part of the distal tip of the probe had detached inside the patient.Reportedly, the patient was sent for x-ray and the missing tip was found in the patient¿s duodenum.The procedure was completed with another injection gold probe¿.Despite numerous attempts boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event.Should additional relevant details become available a supplemental report will be submitted.
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