MAUDE Adverse Event Report: CAREFUSION, INC FLAT NOSE GRASPER D-JAW 5MM 45CM RATCHET; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number SP90-6271

Device Problems Break (1069); Fracture (1260)

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4) 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.

Event Description

A pair of flat nosed graspers broke intraoperatively.The breakage was discovered by a sterile processing technician.Upon further investigation and subsequent scans, the piece was located inside the patient.The patient underwent a diagnostic laparoscopy where the piece was found embedded in the appendix, resulting in an appendectomy.

Manufacturer Narrative

(b)(4) supplemental emdr.A physical sample was not available for manufacturing evaluation.However, a representative photograph of the distal tip was provided by for review.The lot number of the device was not reported and without a physical sample the engineer was unable to identify the lot.Therefore, a review of the device history report could not be performed and no trending specific to a shop order could be performed.Upon review of the provided photograph, it was determined that it showed the distal most inch of the device and it depicted that one half of the jaw had fractured through both the tungsten carbide insert, and the parent metal.The image size is 382 pixels x 356 pixels, and as such, does not provide much additional detail.Due to the low quality of the image and the singular perspective, it cannot be determined if there was any discoloration or deformed metal around the fracture plane.Because a sample was not returned, the jaw assembly which failed cannot be inspected for any dimensional non-conformities that could have potentially contributed to the reported failure mode.Without a physical sample or a date code a more thorough investigation could not be performed.Also, the photograph provided was of too low of a quality to yield any details about the state of the fracture plane other than that it exists.Therefore, the reported failure mode was confirmed, but a root cause cannot be determined.Please be advised that returning the complaint sample would enable the manufacturing facility to perform a more effective investigation into why the reported failure mode occurred.Device was not returned.Photos of defect were provided for investigation.

Event Description

A pair of flat nosed graspers broke intraoperatively.The breakage was discovered by a sterile processing technician.Upon further investigation and subsequent scans, the piece was located inside the patient.The patient underwent a diagnostic laparoscopy where the piece was found embedded in the appendix, resulting in an appendectomy.

• Brand Name: FLAT NOSE GRASPER D-JAW 5MM 45CM RATCHET
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• MDR Report Key: 11096241
• MDR Text Key: 224414306
• Report Number: 1423507-2020-00063
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10885403158858
• UDI-Public: (01)10885403158858
• Combination Product (y/n): N
• PMA/PMN Number: K930666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SP90-6271
• Device Catalogue Number: SP90-6271
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention