Product complaint #: (b)(4).This report is related to a journal article, therefore, no product will be returned for analysis and the manufacturing record evaluation cannot be reviewed as the lot number has not been provided.If further details are received at a later date a supplemental medwatch will be sent.Citation: the american surgeon april 2020 vol.86.
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It was reported via a journal article: title: 'oxidized regenerated cellulose during laparoscopic cholecystectomy increases the risk of rehospitalization'.Authors: mohamed abou arisheh, m.D., moris venturero, m.D., paul froom, m.D.Citation: the american surgeon april 2020 vol.86.This retrospective study aimed to present that oxidized regenerated cellulose (orc) is effective in controlling excessive bleeding, improves operative field visibility, and could decrease the risk of conversions from a laparoscopic to an open cholecystectomy but might cause increased morbidity after discharge.Between october 1, 2014 and january 31, 2018, there were 530 laparoscopic operations in which 182 (n=117 female, n=67 with age more than or equal to 65 years) required the use of orc (surgicel) (ethicon) to control bleeding.Prophylactic antibiotics consisted of a single dose of cefazoline were given unless there was evidence of acute cholecystitis when the treatment was ceftriaxone and metronidazole for 5 to 7 days.Complaint included diagnosis of subhepatic abscess (n=7 out of 182 patients treated with orc) where the patients were re-hospitalized.These patients were treated with antibiotics and drainage, and the abscess resolved over 10 to 21 days of hospitalization.The seven patients are as follows: (b)(6) year-old male was re-hospitalized after 5 days with symptoms of fever and pain, ct scan showed multiple abscesses with bacteria of enterococcus faecalis, klebsiella pneumonia, and enterococcus faecium and spent 21 days in hospital; (b)(6) year-old female was re-hospitalized after 11 days with symptoms of fever and pain, ct scan showed a 7cm abscess with bacteria of klebsiella oxytoca and spent 10 days in hospital; (b)(6) year-old male was re-hospitalized after 4 days with symptom of fever, ct scan showed a 5cm abscess with bacteria of k.Pneumoniae, escherichia coli, and e.Faecalis and spent 12 days in hospital; (b)(6) year-old female was re-hospitalized after 19 days with symptoms of fever and pain, ct scan showed a 11cm abscess with bacteria of e.Faecium and e.Coli and spent 17 days in hospital; (b)(6) year-old female was re-hospitalized after 11 days with symptoms of fever and pain, ct scan showed a 9.5cm abscess with bacteria of e.Coli and k.Pneumoniae and spent 13 days in hospital; (b)(6) year-old female was re-hospitalized after 5 days with symptoms of fever and pain, ct scan showed a 6cm abscess with bacteria of enterobacter cloacae and spent 10 days in hospital; (b)(6) year-old female was re-hospitalized after 29 days with symptom of pain, ct scan showed multiple abscesses with bacteria of pseudomonas aeruginosa and spent 10 days in hospital.The data presented in the study showed that the use of orc is a rapid way to stop bleeding and improves visibility of the surgical field, cutting down operation time and perhaps conversion rates to open operations, without the potential damage from electrocautery.
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