MAUDE Adverse Event Report: ETHICON INC. SURGICEL ORIGINAL 2INX14IN(5.1CMX35.6CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Model Number	1951
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Not Applicable (3189); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: date and name of index surgical procedure? the date is unknown.The procedure is renal transplantation.The diagnosis and indication for the index surgical procedure? no further information is available.Relevant patient history? focal segmental glomerulosclerosis(fsgs).20 years of dialysis.Any concurrent use of other products? tissue adhesive sheet (taco seal).Lot #? no further information is available.What was the intended use of the surgicel? used for hemostasis and no further information is available.Where was the surgicel used (on what tissue)? no further information is available.How much surgicel was used during the procedure? no further information is available.Was the surgicel product left in place? was the excess irrigated and removed? no further information is available.What were current symptoms following the index surgical procedure? onset date? no further information is available.Has any surgical or medical intervention been performed? ureteral stent was placed and ureteral transplant was performed.What is physician¿s opinion as to the etiology of or contributing factors to this event? the surgeon commented that stricture due to ureteral ischemia may be considered, when observed by naked eyes.But ¿the side effect¿ of the package insert on the surgicel is described as foreign body reaction such as ureteral obstruction, and stricture due to this surgicel effect was also considered.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative ureteral stenosis and hydronephrosis? no further information is available.What is the patient¿s current status? no further information is available.No further information will be provided.
Event or Problem Description
It was reported that a patient underwent a renal transplantation procedure on unknown date and absorbable hemostat was used.Ureteral stenosis and hydronephrosis were found postoperatively, and a ureteral stent was placed.The ureteral stenosis did not improve even after transurethral dilatation of the ureter, and one year after the transplantation, a transplanted ureter and an autoureteral anastomosis were performed.The surgeon opines stricture due to ureteral ischemia may be considered, when observed by naked eyes.But the side effect of the package insert on the absorbable hemostat is described as foreign body reaction such as ureteral obstruction, and stricture due to this absorbable hemostat effect was also considered.Additional information was requested.

• Brand Name: SURGICEL ORIGINAL 2INX14IN(5.1CMX35.6CM)
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10169874
• Report Number: 2210968-2020-04645
• Device Sequence Number: 14030869
• Product Code: LMG
• UDI-Device Identifier: 10705031003019
• UDI-Public: 10705031003019
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1951
• Device Catalogue Number: 1951
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR