(b)(4).Evaluation summary: post market vigilance (pmv) led an evaluation of one purstring device.The visual inspection and functional evaluation of the device had acceptable results.The reported condition was not confirmed.The product analysis concluded there were no device abnormalities that would have caused or contributed to the reported incident.Therefore, our investigation was unable to establish a relationship between the device and the reported incident.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.
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According to the reporter, during a high anterior resection, the anastomosis was performed with the device, however, mucosa was not completely resected.The surgeon used the device for suture and then performed anastomosis with the device.After that, they noted that mucosa was not completely resected.They requested evaluation of the psi.As the donuts were completed, the staple line was reinforced with additional suturing.The device was not reprocessed/re-sterilized prior to use as a new stapler fired over the original staple line or did additional tissue have to be transected to complete the procedure: as the donuts were completed, the staple line was reinforced with additional suturing; can you confirm that product is available and will be returned for evaluation: yes; was any reinforcement material used in conjunction with the stapling device: no.
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