MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 30IN 4-0 D/A BB; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	X581H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Foreign Body Reaction (1868); Inflammation (1932)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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: as of august 30, the patient had recovered after reoperation, but still remained hospitalized.Inflammation occurred strongly on the site where non-absorbable sutures were used.Surgeon¿s comment - the event was not caused by the sutures only.Inflammation reaction also occurred at another surgical wound closed with pds, so the patient¿s constitution would be also a factor.The patient demographic info: age, weight, bmi at the time of index procedure =>no further information is available.Date of the index surgical procedure.No further information is available.Can you explain what is meant by ¿suturing for petersen¿? petersen's defect means the gap between the transverse colon and the elevated jejunum no further information is available.On what tissue was the suture used for petersen? see above.Was the same product code of the ethibond suture used ¿for petersen¿? no further information is available.What was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? strong inflammatory reaction occurred, and the sutured site became very hard.Preoperative tissue condition is unknown.Was there any medical intervention performed for the inflammatory reaction ¿for petersen¿? re-operation.What was the peritoneum tissue condition ie., normal or thin, calcified, fragile, diseased? strong inflammatory reaction occurred there too, and abscess appeared.Preoperative tissue condition is unknown.What was the onset date of symptoms from the initial surgical procedure? no further information is available.What was the location of the abscess? mesentery using ethibond.Was the abscess located at the peritoneum closure site? mesentery using ethibond.How was the diagnosis of abscess made? no further information is available.Were any cultures performed? if so, what are the results? no further information is available.What was the date of the re-operation? no further information is available.What was the indication for the second procedure? no further information is available.Other relevant patient history/concomitant medications.No further information is available.Do you have any suture for return and evaluation? no sample will be returned.What is the physician¿s opinion as to the etiology of or contributing factors to this event? the patient¿s constitution.What is the patient¿s current status? still remained hospitalized.No further information will be provided.Reoperation was performed, but specific treatment details (cleaning, removal of inflamed tissue, etc.) are unknown.
Event or Problem Description
It was reported that a patient underwent a surgery for esophageal cancer on an unknown date and suture was used for interrupted suturing for petersen.After the surgery, strong inflammatory reaction occurred, the sutured site became very hard and abscess appeared.Re-operation will be performed.Additional information was requested.

• Brand Name: EB EXC GRN 30IN 4-0 D/A BB
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 9083125
• Report Number: 2210968-2019-87814
• Device Sequence Number: 19508107
• Product Code: GAT
• UDI-Device Identifier: 10705031057661
• UDI-Public: 10705031057661
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946173
• 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): 08/26/2019

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 Catalogue Number: X581H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/18/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention