MAUDE Adverse Event Report: AESCULAP INC ADSON FORCEPS TC 120MM 1 X 2 TEETH; BASIC INSTRUMENTS

Model Number US109

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2020

Event Type  Injury  

Manufacturer Narrative

If additional information or investigation results become available, a supplement will be submitted.

Event Description

It was reported that there was an issue with an adson forceps.The carbide insert on the device broke into pieces and fell into the patient.The surgeon was able to remove the pieces which caused a delay (less than five minutes).All pieces were visible with and easily retrieved.An alternative device from the set (another pattern) was readily available and used to complete the procedure.An additional medical intervention was necessary.The patient was noted to be stable.Additional patient information is not available.The adverse event is filed under reference (b)(4).

Manufacturer Narrative

If additional information or investigation results become available, a supplement will be submitted.

Event Description

Additional information was received via receipt of mw 5097029: the teeth portion on the adson forceps separated and came off; this occurred when making the initial incision.

Manufacturer Narrative

Investigation problem description tc 1 - tooth side - completely missing tc 2- tooth side - partially missing visual inspection stains, scratches and signs of use were visible on the surface.The markings were very pale but toothing was intact.Batch review some batches were partially reworked due to pores in the solder.These pores were only a visual defect and not the cause of the tc fracture.Analysis of root cause the condition of the forceps suggests that they were in regular to frequent use.Possible causes for the tc leaflet falling off may be mechanical impact and/or incorrect reprocessing in conjunction with exceeding the service life.Due to the missing lot number and information on reprocessing, a well-founded analysis as well as traceability is not possible.Although the failure mode was confirmed, a manufacturing or design related issue was not found.

• Brand Name: ADSON FORCEPS TC 120MM 1 X 2 TEETH
• Type of Device: BASIC INSTRUMENTS
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 10726678
• MDR Text Key: 212758019
• Report Number: 2916714-2020-00575
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 04046955076949
• UDI-Public: 4046955076949
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2020,09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: US109
• Device Catalogue Number: US109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/23/2020
• Distributor Facility Aware Date: 09/23/2020
• Event Location: Hospital
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention