MAUDE Adverse Event Report: MEDSORB DOMINICANA, S.A. KITTNER, LAPROSCOPIC BLUNT DISSECTOR; DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	28-0801
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "laparoscopic dissector tip broke off in patient.Tip was retrieved and no injury occurred to patient." deroyal industries, inc.Requested the return of the device but it was unavailable for return.A supplier corrective action request (scar) will be issued to the supplier.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report when additional information becomes available.
Event or Problem Description
A user facility reported, "laparoscopic dissector tip broke off in patient.Tip was retrieved and no injury occurred to patient.".
Additional Manufacturer Narrative
A user facility reported, "laparoscopic dissector tip broke off in patient.Tip was retrieved and no injury occurred to patient." deroyal industries, inc.Requested the return of the device but it was unavailable for return.Deroyal reviewed the work order for the lot number of the device and found no issues.An inventory check was performed on 16 cases of finished product and 100 eaches of the raw material from the supplier and all were found to be acceptable.The risk analysis was reviewed and was found to be up to date and did not require any updates.A supplier corrective action request (scar) will be issued to the supplier, (b)(4).The supplier reviewed the device history record, manufacturing process, and complaint records.The inventory and work in process product were also reviewed and found to be within manufacturing specifications.Root cause: while no sample was able to be returned, because of a previous complaint of this nature, the supplier determined the root cause to be an inadequate glue application on the dissector.With the previous complaint, it was discovered that there was a lack of compliance with the procedure.Actions were taken as stated below, but the supplier noted that this work order took place prior to the corrective actions.Corrective and preventive actions: because of the lack of compliance to the procedure, retraining was conducted on the gluing work instructions and states that all work personnel should be retrained every six months on the procedure as well as with training videos showing the proper gluing assembly.Periodic refresher training has also been implemented for inspection associates to ensure consistent understanding of inspection criteria to review the gluing assembly.Deroyal will continue to monitor for trends around this item and issue.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: KITTNER, LAPROSCOPIC BLUNT DISSECTOR
• Common Device Name: DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): MEDSORB DOMINICANA, S.A.; zona franca industrial park; san pedro de marcoris, ; DR
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 22151906
• Report Number: 2320762-2025-00007
• Device Sequence Number: 7849615
• Product Code: GDI
• UDI-Device Identifier: 00749756025355
• UDI-Public: 00749756025355
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 28-0801
• Device Lot Number: 62095391
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown