MAUDE Adverse Event Report: CAREFUSION, INC T/C METZ DISSECT SCISSORS BL/BL CVD 7IN; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Catalog Number MA1601

Device Problem Break (1069)

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

Event Date 08/28/2020

Event Type  malfunction  

Manufacturer Narrative

Pr # (b)(4).On (b)(6) 2020 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event.Writer provided contact information.Device not yet evaluated, if the device is evaluated a follow up will be sent.

Event Description

One of the scissors broke in a patient.03sep2020 additional information: what was the procedure that was being performed? penile implant.Did any part the instrument fall into the patient¿s body, and if so, how was it retrieved? yes, part of the scissors broke off in the patient.They had to perform an xray to see location of the scissor blade.They were unable to retrieve the blade through the original incision without causing further damage.An additional incision was made, and the scissor blade was retrieved.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? yes, x ray was performed and an additional incision on the patient¿s abdomen.What was the patient¿s outcome? the patient¿s outcome did not change except that he had an additional incision.Was the procedure completed as planned? yes.Can you please send all parts of the instrument for evaluation? yes.Do you have photos of the reported issue on the instrument? yes.No further information available.

Event Description

Per email: one of the scissors broke in a patient.(b)(6) 2020 additional information: what was the procedure that was being performed? penile implant 1.Did any part the instrument fall into the patient¿s body, and if so, how was it retrieved? yes, part of the scissors broke off in the patient.They had to perform an xray to see location of the scissor blade.They were unable to retrieve the blade through the original incision without causing further damage.An additional incision was made, and the scissor blade was retrieved.2.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? yes, x ray was performed and an additional incision on the patient¿s abdomen 3.What was the patient¿s outcome? the patient¿s outcome did not change except that he had an additional incision.4.Was the procedure completed as planned? yes 5.Can you please send all parts of the instrument for evaluation? yes 6.Do you have photos of the reported issue on the instrument? yes no further information available.

Manufacturer Narrative

The complaint product was returned, and an evaluation was performed.It was determined that there was a production error.After review of device history record (dhr), it was revealed that correct material was used for manufacturing of instrument and all required processes and intermediate inspections were duly performed.The lot k19xqs was released from supplier as per requirements.Further physical inspection of reported instrument showed rust on and near the screw area.From physical evaluation of the broken scissors, it seems there was a micro crack inside the threaded hole on lower part of the scissors.We conclude that the micro crack opened up by stress in the area caused during sterilization / usage.An internal review of the complaints and the production records, indicates compliance with applicable hardness, functional, and dimensional requirements.The possible root cause of breakage isolated material imperfection (hairline crack) on the inner threaded area, which could not have been detected under product inspection methods in place.A further internal review of scissors, manufactured using the same material batch was performed.From a total 1990 scissors produced using the same material batch, and shipped over a year ago at the time of this report, only 2 scissors from same source (with one sample received back) are reported to have this issue.No further complaints relating to breakage at the time of this report has been received.It appears that this is an isolated incident.

• Brand Name: T/C METZ DISSECT SCISSORS BL/BL CVD 7IN
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 10549143
• MDR Text Key: 221545906
• Report Number: 1423507-2020-00037
• Device Sequence Number: 1
• Product Code: LRW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MA1601
• Device Lot Number: K19XQS
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention