MAUDE Adverse Event Report: AESCULAP AG NOIR IRIS WVCT SCISSORS CVD.S/S 110MM

Model Number BC211WB

Device Problems Material Separation (1562); Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

No product at hand.Batch history review: the product does not require batch management; a review of the device quality and manufacturing history records is not possible.Conclusion and root cause: no product available and therefore it is hardly possible to determine an exact conclusion and root cause.We assume that the cause of the failure is not product related.There is the possibility that the root cause of the problem is most probably usage related.Rationale: according to the quality standard a material defect and production error can be excluded.Without the product we cannot determine the exact cause.There is the possibility for a usage error due to improper handling or mechanical overload situation.If further investigations are required, the product should be provided for examination.No capa necessary.If additional is received a follow up report will be submitted.

Event Description

It was reported that during a surgical breast procedure the scissor tips broke while cutting breast tissue.A pair of back up scissors were retrieved to complete the procedure.This incident did not cause or contribute to a serious injury, death or a delay in surgery.No other information has been provided.Additional information has been requested, however, not yet received.

Manufacturer Narrative

B5: updated.Device: bc211wb; noir iris wvct scissors cvd.S/s 110mm; 4509160712 batch number (update); 02.03.2018 production date (update).The instrument arrived in a decontaminated condition and it is available for investigation.The broken off parts are missing.Investigation - carried out visually and microscopically.Here we found 2 broken off tips.Additionally we made an optical inspection of the fracture surface.Here we detected unknown deposits and yellow brown discoloration but no anomalies.Furthermore we discovered brown stains/discolorations or rust formation around the hinge area that has been chafed.We also found pitting, dark staining, and material erosion at soldering points.Brown stains/discoloration were also detected.Batch history review - the device quality and manufacturing history records have been checked for the lot number and found to be according to the specifications valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause - the root cause of the problem is most probably usage a reprocessing related.Rationale - according to the quality standard and dhr files a material defect and production error can be excluded.No pores or inclusions could be found on the point of rupture.Investigations lead to the assumption that the breakage of the tips were caused by an improper handling due to an overload situation and an additionally reprocessing failure.There is the possibility for pre-damage or similar due to previous surgeries.The brown stains/discolorations or rust formation around the hinge area could be caused due to insufficient lubrication and/or foreign bodies.This could lead to corrosion of the metallic friction surfaces that move relative to each other (especially in locks/joints and sliding paths).This forms micro-abrasion, which can make the surface extremely rough and destroy the passive layer.In these sensitized areas, humidity or deposits (e.G.Blood residues) can easily accumulate - a process that usually leads to corrosion.If this occurs, then discard the defective instruments or have them repaired where possible.Some preventative measures would be proper instrument care and servicing or distribute the care product uniformly in the joint by opening and closing the instrument in the joint area several times.Additionally, we assume that the discoloration are pinprick-like corrosion holes surrounded by sparkling, reddish-brown or multi-colored corrosion spots, often associated with circular corrosion deposits around the corrosion hole.The following points could be the cause of this: - exposure due to halide ions, especially chlorides - dried on organic residues - pitting due to liquids with high chloride content or more specifically due to dry residues of such liquids - brand new instruments are particularly susceptible to chlorides due to their still thin passive layer.Corrosion products can be dissolved with an acid-based detergent used in accordance with manufacturer's instructions.Preventive measure would be largely avoided by using low-chloride water qualities, and minimizing organic residues.There is also the possibility that the pitting was caused due to etching effect.Furthermore, there are many points and caution must be observed, as stated in the instructions for use (ifu).

Event Description

Further clarification received : the tip of the scissor blade had been broken but it did not fall into the sterile field or into the patient.All pieces were retrieved.There was no patient harm and no medical intervention required.

• Brand Name: NOIR IRIS WVCT SCISSORS CVD.S/S 110MM
• Type of Device: NOIR IRIS WVCT SCISSORS CVD.S/S 110MM
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8460189
• MDR Text Key: 140173551
• Report Number: 9610612-2019-00199
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC211WB
• Device Catalogue Number: BC211WB
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/18/2019
• Date Manufacturer Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1