MAUDE Adverse Event Report: ETHICON INC. SURGICEL ABSORBABLE HEMOSTAT UNKNOWN; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4) d4: udi: as the catalog/model number was not provided, the (01)gtin is not available.H6.Component code: g07002 - device not returned 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: 1.What is the total number of ssi¿s due to surgicel powder? ¿ 12 total- 2 of them in colorectal cases.10 of them in hysterectomy cases (7 of these 10 since september 2024) ¿ rcas have been conducted for each of these ssi incidents ¿ original to date of event ranges from 2-15 days; average of 9 days ¿ no root cause has been identified.The only commonality is that each of these patients had surgicel used on them.No commonality in surgeons or staff either.¿ reps conducted tabletop education and learned that the use of surgicel causing these infections is inconclusive.It is also not clear which form of surgicel was used.Infection control asked reps to complete education as a safeguard.It is not clear what exactly is causing the increase in infections.2.Have any of the cases been previously reported? is so, please provide the respective reference numbers.None the customer shared that the infections have occurred in tlh and colorectal procedures.They didn¿t specify if it was robotic or lap.For the colorectal, they didn¿t mention which specific procedure.Do you know if the users irrigated and suctioned excess? and are they previous arista users? yes, this facility was a previous arista user.I asked if they irrigated when powder was used and bridget was unsure.She didn¿t give exact surgeon names to follow up with.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.1.What were the diagnosis and indication for the index surgical procedure? 2.Was there any intraoperative concurrent use of other products? 3.What is the lot number? 4.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? 5.Where was the surgicel used (on what tissue)? 6.How much surgicel was used during the procedure? 7.Was the surgicel product left in place? was the excess irrigated and removed? 8.Were cultures performed? if yes, results? 9.Has any surgical or medical intervention been performed? 10.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative ssi? 11.What is the patient¿s current status? 12.What is the users experience w/ surgicel powder and other hemostatic agents? this report is being submitted pursuant to the provisions of 21 cfr part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent a hysterectomy procedure on an unknown date and absorbable hemostat was used.The surgeon stated that in infection prevention at the facility there has been an increase in ssi's reported due to absorbable hemostat conversion since the (b)(6) 2023.The facility believes the cause is the absorbable hemostat, as that is the only change that happened since this increase in ssis and it is all happening in hysterectomy procedures.Before, the facility was using.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected information: d 3.Manufacturer email.Additional information was requested, and the following was obtained: we have been in touch with infection control with the hospital.Infection control and myself spent several days at a display in the surgeons lounge inservicing the surgeons on surgicel powder.Some were not irrigating away excess.We have addressed this issue.The infection control director told me she thinks a few of their ssi dings were perhaps surgicel placed in surgery instead of actual ssi cases.We have since educated the hospital, surgeons, er, and infection control even set up meetings with myself and the doctors reading the ct scans.They were very interested in getting the entire building educated.This all happened jan- april.This report is being submitted pursuant to the provisions of 21 cfr part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SURGICEL ABSORBABLE HEMOSTAT UNKNOWN
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20898093
• Report Number: 2210968-2024-13175
• Device Sequence Number: 4702646
• Product Code: LMG
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown