MAUDE Adverse Event Report: RICHARD WOLF GMBH METZENBAUM SCISSORS INSERT

Model Number	83930041
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The (b)(6) metzenbaum scissors insert from batch 1409227 was checked in the specialist department, where it was found that the bonded ceramic blade had fallen off the carrier part.The scissor parts show strong signs of wear as well as annealing colours due to strong heat development.Damage to the scissor parts indicates mechanical overload.The adhesive surface is almost completely present, so that the damage was caused by the thermal stress during the hf application.On the basis of the available information, a user error can be assumed.Taking into account all the findings obtained, no systematic errors can be derived either with regard to the functionality or from a design and manufacturing point of view.When used as intended and in compliance with the safety instructions given in ga-b241, the eragon bipolar metzenbaum shears (b)(6) will not be affected by thermal stress with hf current.In the instructions for use ga-b 241, reference is made to the limited stability of the products in chapter 7 applications.Products must be checked immediately before and after use for damage, loose parts and completeness.Chapter 7.4 application notes contains detailed information on the possibility of breakage or damage.Due to the small dimensions required, the products have only limited stability.For bipolar instruments, damage to the insulation caused by overloads can also lead to an impairment of electrical safety.If the coagulation effect is suddenly absent, do not increase the hf power arbitrarily, if necessary carry out a function test (see chapter 8.2.1).For therapeutic applications, we recommend keeping a replacement instrument at hand.Only grasp and remove small, soft tissue parts/organs with the products.Shock-sensitive ceramic components (scissors) should be handled with particular care.Hf instruments in combination with hf surgical units should only be used with a recurring peak voltage of 300 v maximum.Use with bipolar cutting current (cut mode) is not permitted.The products are only suitable for short-term coagulation of tissue and smaller vessels (e.G.Tubular structures, blood vessels).During the check in chapter 8, visual check in chapter 8.1 and the function test 8.2.1, damage such as in this case is detected early so that the user can switch to a replacement instrument.Products that are damaged and incomplete or have loose parts must no longer be used.Rwgmbh considers this report closed.If any additional information is obtained, a follow up report will be submitted to the fda.
Event or Problem Description
On august 20, 2019, richard wolf gmbh (rw gmbh) received the following information: during intraoperative use of the bipolar scissors, the ceramic blade at the distal end of the instrument fell off during application under hf (hf generator: martin maximum me402).The ceramic blade was completely recovered.No significant surgery time extension is reported.The ceramic was fully recovered from the patient during the surgery.The application was completed.No deterioration of the patient's condition after application.

• Brand Name: METZENBAUM SCISSORS INSERT
• Common Device Name: METZENBAUM SCISSORS INSERT
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 9764256
• Report Number: 9611102-2019-00027
• Device Sequence Number: 18964463
• Product Code: HET
• UDI-Device Identifier: 04055207026588
• UDI-Public: 04055207026588
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K033177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 83930041
• Device Catalogue Number: 83930041
• Device Lot Number: 1409227
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR