MAUDE Adverse Event Report: CAREFUSION, INC MCKERNAN ALLIS GRASPER 5MM 36CM RATCHET; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	SP90-6314
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr (b)(4) initial mdr.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.
Event or Problem Description
It was reported that the graspers have a silicone seal at the proximal end of the shaft and may cause flaking.
Additional Manufacturer Narrative
(b)(4) supplemental emdr, upon receipt the returned sample received a visual examination and a functional check.The following markings were found on the device: 90-6378, c20, a 2-d udi barcode, ce0123, and snowden pencer.It was initially reported that the device sp90-6314 had a date code of a20, however, the device that was returned was a sp90-6378 with a date code of c20.Upon visual inspection, the failure mode of flaking was not confirmed.The silicone observed at this location was part of the design of this device, it was intended to provide a barrier to obstruct fluid flow from entering the knob from this joint.The silicone used in this location was a medical grade silicone adhesive.It was installed onto the instrument by applying the adhesive around the shaft, just distal of the hole in the shaft for the flush port.The knob was then slid on from the proximal end in the distal direction, thus trapping silicone between the shaft and the knob, and sweeping any excess to the distal end of the knob where its presence was observed.Per the technical data sheet for this adhesive, ¿after final cure, the resulting silicone elastomer possesses the appearance, texture and general composition of many conventional silicone elastomers,¿ and is ¿used to permanently bond materials.¿ as a viscoelastic substance, this material does not flake apart, for it to separate from itself requires an outside force to pull it apart.Furthermore, no complaints have been identified where the silicone was observed to have flaked off the device spontaneously, nor were any complaints identified where the silicone was observed to separate from the device and fall into the patient.Based on the information provided by the manufacturer, and the absence of complaints indicating that flaking has been observed to spontaneously occur, the silicone adhesive applied at this location should not separate from this device unless an intentional effort to separate or clean it from the device or certain solvents are used.The ifu for this device does not instruct the end user to utilize any of these solvents, or to clean away this adhesive.Concerning the appearance of this adhesive at this location, the corner joint where it is present does not provide the opportunity to polish the adhesive to a smooth and consistent surface, doing so would risk compromising the insulation of the shaft.The manufacturer of the adhesive specifically states that ¿any shaping of the uncured adhesive should be complete before the skin forms.¿ based on the physical state of the adhesive at the knob, no non-conformance or manufacturing defect was present.Based on the absence of a history of silicone separating from this joint during surgical use, the fact that this silicone was intentionally applied at this location and does not represent a non-conformance per the assembly print for this device, or per the final inspection criteria for endoscopic devices, the reported failure mode was not confirmed, and the most probable root cause of this failure mode was determined to be customer preference.A replacement device will be issued for this incident.H3 other text : evaluation has been performed.
Event or Problem Description
It was reported that the graspers have a silicone seal at the proximal end of the shaft and may cause flaking.

• Brand Name: MCKERNAN ALLIS GRASPER 5MM 36CM RATCHET
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• MDR Report Key: 10863501
• Report Number: 1923569-2020-00001
• Device Sequence Number: 2671389
• Product Code: GEI
• UDI-Device Identifier: 10885403159008
• UDI-Public: (01)10885403159008
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K930666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021

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: SP90-6314
• Device Catalogue Number: SP90-6314
• Device Lot Number: C20
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other