MAUDE Adverse Event Report: CAREFUSION, INC NON-RATCHETED HANDLE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	SP95
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, "the post for the monopolar cord sheared from the handle." customer confirmed that the issue was found after use during reprocessing.No patient harm or injury was associated with this incident.
Additional Manufacturer Narrative
Pr 4778822 initial emdr.A device is anticipated for investigation.Once the investigation has been completed a supplemental emdr will be submitted for the investigation results.If any additional information is received a supplemental will be submitted with those details.
Additional Manufacturer Narrative
(b)(4).Supplemental emdr.Investigation findings: upon receipt the returned sample received a visual examination and functional check.The following markings were found on the device: sp95, a date code of h21, a 2-d udi barcode, snowden pencer, (b)(6), and usa.Upon visual inspection and functional check, the reported failure mode was confirmed.The bovie post had separated from its receptacle at the top of the handle bearing/knob.Normally, the bovie post fastened into the rotation knob bearing through the handle.The knob/bearing assembly was still intact and did not separate from the handle.Furthermore, it was observed that approximately 0.770 inch of the 0.865-inch bovie post had sheared off, leaving approximately 0.095-inch remaining of the post retained inside the knob/bearing assembly.This small remainder was holding the assembly together.Examination of the broken edges on both the internal and external ends indicated possible heavy forces and/or mechanical overstress causing the metal to shear off in a single directional manner.No other signs of damages, excessive forces cracking, or breaking was observed across the remainder of the sample.The bovie post was joined to the bearing using a uv luminescent thread locking adhesive.Evidence of this adhesive was found on the surfaces adjacent to the through hole in the handle for the bovie post.The practice of using thread-locking adhesive was to dip the threads of the male component into a pool of the thread locking adhesive, then fastened the two threaded components together.This act trapped the thread locking adhesive in the space between the internal threads of the bearing and the external threads of the bovie post.It was obvious that the thread locking adhesive was applied, due to the post not failing at the threads.Finally, due to the bovie post breaking along its metal distal end, it was tested for proper hardness specification.Per product specifications, the hardness range was noted to be within tolerances on the broken bovie post piece.Furthermore, the broken post was measured and found to be within product specifications.Upon further examinations the proximal end which had the splayed tips, displayed a possible sign of damage and/or heavy force application.The damage was characterized as a flattening/deformation of the metal surfaces at the very tip ends.The damage was on both sides of the split in the post, with both flats forming two inline planes, and suggested that as a strong force was acting to pull the bovie post in a single direction, which the concentrated force acted to flatten the tip while snapping most of the bovie post from the base that was secured to the bearing.Based on the gathered information it was clear that the sample¿s failure was causing by excessive forces placed on the bovie post end causing it to break off.Additionally, the sample was confirmed to have been manufactured correctly.
Event or Problem Description
It was reported that, "the post for the monopolar cord sheared from the handle." customer confirmed that the issue was found after use during reprocessing.No patient harm or injury was associated with this incident.

• Brand Name: NON-RATCHETED HANDLE
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• Manufacturer (Section G): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 13950706
• Report Number: 1423507-2022-00009
• Device Sequence Number: 17220804
• Product Code: GCJ
• UDI-Device Identifier: 10885403171444
• UDI-Public: (01)10885403171444
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K991928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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: SP95
• Device Catalogue Number: SP95
• Device Lot Number: H21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown