MAUDE Adverse Event Report: CAREFUSION, INC "GRASPER, WAVY DOUBLE-ACTION, 36CM"; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number SP8384

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If further information becomes available a follow up medwatch will be submitted.

Event Description

Tip of instrument broke off inside the patient.The date of the event was (b)(6) 2018, the patient was a (b)(6) female, (b)(6).The grasper was grasping bowel, the patient had no injury or intervention, stable after event, the tip popped off and had to be retrieved with another grasper from the abdomen of the patient.No additional medical procedures.The device was removed from use and replaced.The lap gastric sleeve was completed as planned.(b)(4).

Event Description

Tip of instrument broke off inside the patient.The date of the event was (b)(6) 2018, the patient was a (b)(6), female, height 165.1cm, the grasper was grasping bowel, the patient had no injury or intervention, stable after event, the tip popped off and had to be retrieved with another grasper from the abdomen of the patient, no additional medical procedures, the device was removed from use and replaced, the lap gastric sleeve was completed as planned, the facility did not report to the fda the product number for the tube and handle used in the event was: sp83, sp94.

Manufacturer Narrative

(b)(4).Device manufacture date: august 2017.Device history record: all steps were initialed and dated as complete and no material substitutions were made.Upon receipt the complaint sample received a visual inspection.The following markings were identified on the complaint sample: ce0123, usa, sp8384, and h17.Visual inspection identified that the pin that connects the actuating rod to the links had sheared apart at two locations.A piece of the actuating rod-links pin was found in the actuating rod, another was found in one of the two double action links.The thickness of the links at the pin hole, the thickness of the actuating rod at the pin hole, and the diameter of the actuating rod-link pin were all found to be within pre-assembly component specification using calibrated calipers.The pin is made of a material that does not undergo any additional processes for increased strength.These observations indicate the device was manufactured with the pin most likely at its design strength, and that the strength of the pin was exceeded in use by the customer.The pin segment found in the actuating rod was.041¿ in length, the pin segment in the link was.019¿ in length.This is not the total length of the pin which indicates that the pin also sheared apart from the segment in the other link, and that third segment of the pin is missing.The pin material was inspected under magnification and found to have suffered damage from shearing stress.This damage may have occurred over a single incident, or a number of incidents, until the damage and plastic deformation weakened the pin to the point of fracture.A burr on one link rivet was observed to be rubbing against the clevis wall as the jaw it is attached to was moved toward the closed jaw position.The customer did not complain about difficulty closing the jaw prior to the incident, and the rubbing is not difficult to overcome in its current state.It is most likely that the same incident, or incidents that causing shearing damage to the actuating rod¿links pin also caused plastic deformation of the rivet that kicked up a peened edge of the rivet out of its joint enough to start rubbing against the clevis the most likely cause of the complaint failure mode was mechanical overstress.There was no indication of damage to the link or the actuating rod, indicating the actuating rod-link pin was properly joined to the other component prior to one or multiple mechanical overstresses that sheared the pin into three separate pieces.One segment is missing from the complaint sample and likely ejected from the device after the pin sheared apart.Conclusion(s): the most likely root cause of this complaint failure mode was mechanical overstress by the customer.There was no damage to the links or the actuating rod, but the actuating rod-link pin was identified as having sheared into 3 separate pieces, one of which was missing from the complaint sample.This indicates that the customer overstressed the device until the pin sheared apart at the interface between the actuating rod and the two links, resulting in two shearing planes.The complaint log was reviewed and it was identified that the customer has had one other complaint within the last year where mechanical overstress was identified as the most likely cause, complaint (b)(4) with an awareness date of 26apr2018.Recommend advising customer that ifu 36-0161 directs user to avoid mechanical overshock or overstressing the devices, as this will cause damage, and that overstressing the device or mechanical overshock may occur at any point while handling the instrument, not only surgery.

• Brand Name: "GRASPER, WAVY DOUBLE-ACTION, 36CM"
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• MDR Report Key: 7752528
• MDR Text Key: 116104613
• Report Number: 1923569-2018-00015
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K991928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SP8384
• Device Lot Number: H17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Date Manufacturer Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Weight: 127