MAUDE Adverse Event Report: RICHARD WOLF GMBH HYSAFE; SCISSORS INSERT WITH SHEATH 5FR WL 340MM

Model Number 86426818

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

According to the manufacturer: the customer has complained that when opening and closing the jaws several times (5-6 times), the pin that connects the jaws of the scissors comes off easily, which causes a problem during the operation, as this pin is sharp and could unintentionally injure the tissue.There is also a problem when pulling the scissors out of the working canal, as this pin can damage the working canal.There is also a risk of the pin falling into the patient during surgery.The 86426818 scissor-inner-part m.Shaft 5ch nl 340mm with batch 4500329931 was checked in the responsible department.It was found that the riveting of the movable shear part to the fixed shear part is defective.The pliers also show severe damage to the shaft (pliers tube severely bent).The cause can be attributed to mechanical overload.Taking into account all the findings determined, no systematic defects can be deduced either in terms of functionality or from a design - and manufacturing - point of view.The user has identified this defect during the op.The present inner part of the scissors type 8642.6818 originates from the order production order (b)(4) with an order size of 180 pieces and was added to the new goods warehouse on 16.09.2021.Company "medin a.S." has confirmed with the inspection instruction 01-001-8653 the inspection of the production lot without any abnormalities, return deliveries or special releases.The delivery to the customer took place on 29.11.2021 with delivery bill 82043172.Possible hazards were or were not considered in the risk assessment b1-2 with the corresponding extent of damage and probability of occurrence.In the associated instructions for use ga-s016 /en/ 2019-10 v5.0 / pk19-975 contains applicable warnings for these errors: 9 applicationwarning! limited stability of the products!excessive application of force will cause damage, impair function and thus endanger the patient.Do not use products that are damaged, incomplete or have loose parts.No missing parts may remain in the patient.Check products immediately before and after use for damage, loose parts and completeness.Warning!risk of injury if the instrument is not in the surgeon's field of vision!unintentional tissue damage as well as damage to the distal end of the endoscope and to the instrument parts is possible.'insert the instrument only under visual control.'perform manipulations only when the instrument appears completely in the field of view of the endoscope.10 inspectionwarning! injuries due to damaged or incomplete products!injuries to the patient, user and third parties are possible.Perform checks before and after each use.Do not use products that are damaged, incomplete or have loose parts.Do not attempt to carry out repairs yourself.Caution!send damaged or incomplete products with loose parts for repair.For repair.Repair only by authorized specialists.10.2 visual inspectioncaution! limited stability of the products!perform visual inspections before and after each use.Do not use damaged products.Check instruments, especially in the distal area, and accessories for:' damage' surface changes (e.G.Corrosion)' intactness of sharp cutting edges' unintended, traumatizing geometries ' sharp edges' loose or missing parts' rough surfaces.Check jaw parts for defective cut surfaces and corroded parts.The cut surfaces of the jaw parts must be sharp.Warning!damaged surface in the joint area of the tongs.The joint pin may become loose.Check for surface changes, such as hairline cracks on the joint pin/mouthpiece.Do not use products with damaged surfaces and send them in for repair.10.3 function check check the compatibility of the individual components.Check tight fit of the individual connections.Check ease of assembly of the individual components.Replace productsproducts if the connection does not hold or is difficult to assemble or screw together.Check the opening and closing of the jaws (1.1).If the jaw cannot be closed/opened-disassemble the handle: chapter 9.2, page 14-install the handle: chapter 9.1, page 13check the rotatability of the pincer attachment (1) by means of the rotary wheel (1.7).Rw gmbh considers this matter closed.However, in the event rw gmbh receives any additional information, a follow-up report will be submitted to fda.Rwmic is submitting the report on behalf of rw gmbh.

Event Description

It was reported to richard wolf that: "when opening and closing the jaws a few times (5-6 times) then the pin that connects the jaws of the scissors comes out slightly, resulting in a problem during the operation as this pin is sharp and might hurt the tissue unwittingly.Also, there is a problem when retrieving the scissors from the working channel as this pin can damage the working channel.Furthermore, there is a danger that this pin might fell into the patient during the operation.There was no problem with the patient's health" the manufacturer, rw gmbh, confirmed that "yes the patient was involved and it happened during a procedure.But the cause is user error." (email (b)(6) 2022).

• Brand Name: HYSAFE
• Type of Device: SCISSORS INSERT WITH SHEATH 5FR WL 340MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• MDR Report Key: 14452533
• MDR Text Key: 300348345
• Report Number: 9611102-2022-00021
• Device Sequence Number: 1
• Product Code: OCZ
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K051276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 86426818
• Device Catalogue Number: 8642.6818
• Device Lot Number: 4500329931
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1