MAUDE Adverse Event Report: AESCULAP AG BIPOLAR PREP.SCISSORS FINE TIP 180MM; GENERAL SURGICAL INSTRUMENTS

Model Number BC686R

Device Problems Break (1069); Crack (1135)

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

Event Date 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: failure description, the instrument arrived in a clean status with a broken ceramic insulation.The broken off part is missing.Investigation: we made a visual inspection of the instrument.We found traces of usage and friction points.Additionally we detected a grinding contour.Furthermore we discovered a broken ceramic insulation.An optical inspection of the fracture surface showed dark discoloration but no anomalies were detected.We discovered that the broken ceramic insulation and the friction point is in an alignment.A cutting test was made according to test plan.The test was insufficient.The scissor does not cut according to specifications; to be precise it was very bad or not at all.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: the root cause of the problem is most likely maintenance and usage related.Rationale : according to the quality standard a material defect and production error can be excluded.No pores or inclusions could be found on the point of rupture.Investigations led to the assumption that the breakage was caused due to improper handling in a mechanical overload situation.Possibly the grinding contour could be from repair by a third part.The ats label could be found.The modified cutting edge resulted in a bad cutting geometry and this led to the insufficient cutting test results.The bad geometry led to a possible overload and during cutting the ceramic broke.Due to the alignment of the fracture point and the friction point we assume that the breakage occurred during cutting.We assume that dark discolorations are metal abrasions.Furthermore, according to the instructions for use (ifu), the following points and warnings must be observed: do not use the product if it is damaged or defective.Set aside the product if it is damaged.Damage to the working tips and ceramic parts due to incorrect handling.Do not apply excessive force.Prior to and after each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components.Immediately put aside damaged or inoperative products and send them to aesculap technical service (ats).Risk of injury and/or malfunction - always carry out a function check prior to using the product.After each cleaning, check that the instrument is dry, clean, operational, and free of damage (e.G.Broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components).Check that the product functions correctly.Risk of injury and/or malfunction.Do not modify the product.Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses.For service and repairs, please contact national b.Braun/aesculap agency.

Event Description

It was reported that there was an issue with a bipolar scissor.During an unspecified procedure, the scissor was noted to be cracked.This malfunction was not reported to have caused patient harm or required intervention.A picture showed that the ceramic component at the tip was affected.Additional information was not yet available.

• Brand Name: BIPOLAR PREP.SCISSORS FINE TIP 180MM
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: lindsay chromiak ; 3773 corporate parkway; center valley, PA 18034
• MDR Report Key: 8685093
• MDR Text Key: 147598687
• Report Number: 9610612-2019-00368
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K001330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC686R
• Device Catalogue Number: BC686R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/29/2019
• Date Manufacturer Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1