MAUDE Adverse Event Report: CARL TEUFEL GMBH IRIS SUPERCUT D-EDGES SCISSORS CVD 4-1/2; SCISSORS, GENERAL, SURGICAL

Model Number 32-4705

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

Cfn-(b)(4) on 06sep2017, 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.Three lot numbers (b17xta, xtaz12, and xtax11) used in procedure but it is unknown which instrument broke apart and fell into the patient.No further information available.

Event Description

Customer stated verbally: tips breaking.3 follow ups have been completed to gather additional information.No responses have been received.Additional information 29sep2017: what was the procedure that was being performed? debridements.Did any part the instrument fall into the patient¿s body, and if so how was it retrieved? yes, with product #32-4705, on one occasion by physician manually with forceps.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? no not necessary.What was the patient¿s outcome? no negative outcome.Was the procedure completed as planned? yes, with another instrument.Can you please send all parts of the instrument for evaluation? yes.On 29 sep2017 received the complete response for additional information on these complaints from customer, and cfn-(b)(4) product #32-4705 did have part of the instrument fall into the patient.Changed the aware date in cfn-(b)(4) to 29sep2017 as this is the date we found out which product this event happened with.Three lot numbers (b17xta, xtaz12, and xtax11) used in procedure but it is unknown which instrument broke apart and fell into the patient.No further information available.

Manufacturer Narrative

(b)(4).The sample was provided and an evaluation was performed.The tungsten carbide insert of two scissors is completely broken out on one part, the tungsten carbide insert on the other part is in the original state.On the third scissor, the tip is broken.The surface of the soldering seam has a perfect, even image and shows that the hard metal was soldered in the entire length without any errors.The tip of the obstructed parts is bent inwards by a length of approx.8 to 9 mm sidewise.The tip of the obstructed parts is bent inwards by a length of approx.3.5 mm by 1.5 mm sidewise.This suggests that a very strong lateral pressure exerted on the scissors causing the brazed insert to break off.The foremost tip (0.5 mm) has a glossy surface, indicating a hard contact through a hard object.This is also an indication of an improper lateral pressure.At the part where the carbide is attached, there is a distinct deep impression of the serrations of the other part.Such imprints can only occur when the scissors have been opened and closed in a defective state, i.E.Without the insert on the other side.The breaking-off of the insert is likely to have been caused by an impermissible lateral pressure.The scissors can only be used for cutting normal tissue, not for cutting cartilage or other hard material.There have been no issues identified with the material or manufacturing process.A review of the device history records (dhr) did not identify and issues that would have contributed to the reported issue.

• Brand Name: IRIS SUPERCUT D-EDGES SCISSORS CVD 4-1/2
• Type of Device: SCISSORS, GENERAL, SURGICAL
• Manufacturer (Section D): CARL TEUFEL GMBH; tuttlinger str. 30; liptingen IL 78576 ; GM 78576
• Manufacturer (Section G): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061
• MDR Report Key: 6921717
• MDR Text Key: 90181518
• Report Number: 1423507-2017-00101
• Device Sequence Number: 1
• Product Code: LRW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 32-4705
• Device Lot Number: B17XTA, XTAZ12, AND XTAX11
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1