Device Problems
Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Granuloma (1876)
|
Event Date 07/01/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Report source: literature.The citation of the journal article is below.Dr.Badar hasan is the corresponding author.Colak y, hasan b, tandon k, khan s, wadhwa v, bejarano pa, erim t.Potential clinical complications of orisetm gel use, a new submucosal lifting agent: experience from a tertiary care center and review of the literature.Ann gastroenterol.2022 jul-aug;35(4):407-413.Doi: 10.20524/aog.2022.0726.Epub 2022 jun 2.Pmid: 35784627; pmcid: pmc9210787.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental emdr will be filed.
|
|
Event Description
|
It was reported to boston scientific corporation that orise gel was used as a lifting agent during a colonoscopic emr (endoscopic mucosal resection) procedure on an unknown date.The lesion was reportedly a 20 mm sessile polyp (paris classification is) in the sigmoid colon and the initial histological diagnosis was invasive carcinoma in a tubular adenoma.When visualized on follow-up colonoscopy, the orise material created a mass-like effect.The patient underwent sigmoid resection 46 days after the procedure in which orise was injected.However, no residual adenocarcinoma or high-grade dysplasia was found on the resected surgical specimen.The location of the orise material was the submucosa and muscularis propria, and abundant giant cells were observed at the site of orise gel injection in the resected specimen (foreign body-related granulomatous reaction).
|
|
Event Description
|
It was reported to boston scientific corporation that orise gel was used as a lifting agent during a colonoscopic emr (endoscopic mucosal resection) procedure on an unknown date.The lesion was reportedly a 20 mm sessile polyp (paris classification is) in the sigmoid colon and the initial histological diagnosis was invasive carcinoma in a tubular adenoma.When visualized on follow-up colonoscopy, the orise material created a mass-like effect.The patient underwent sigmoid resection 46 days after the procedure in which orise was injected.However, no residual adenocarcinoma or high-grade dysplasia was found on the resected surgical specimen.The location of the orise material was the submucosa and muscularis propria, and abundant giant cells were observed at the site of orise gel injection in the resected specimen (foreign body-related granulomatous reaction).Additional information received on september 7, 2022: the decision to take the patient to the operating room and perform a surgical resection was the combination of the initial pathology on the patient (invasive carcinoma) coupled with the morphologic findings on surveillance endoscopy (submucosal mass effect).
|
|
Manufacturer Narrative
|
Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1, g2: report source: literature.The citation of the journal article is below.Dr.Badar hasan is the corresponding author.Colak y, hasan b, tandon k, khan s, wadhwa v, bejarano pa, erim t.Potential clinical complications of orisetm gel use, a new submucosal lifting agent: experience from a tertiary care center and review of the literature.Ann gastroenterol.2022 jul-aug;35(4):407-413.Doi: 10.20524/aog.2022.0726.Epub 2022 jun 2.Pmid: 35784627; pmcid: pmc9210787.Block h2: block b5 was updated with additional information received on september 7, 2022.Block h6 device code has been corrected based on the review that the orise gel functioned as intended at the time of emr.Block h6: impact code f19 captures the reportable event of surgical intervention (sigmoidectomy due to "mass-like" appearance of orise gel).
|
|
Search Alerts/Recalls
|
|