MAUDE Adverse Event Report: AESCULAP AG JAW INS.MICRO-DISSECTOR SCISS 5MM 310MM; ENDOSCOPY

Model Number PO602R

Device Problem Break (1069)

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

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

(b)(6).During procedure for gynecology, jaw was broken.When cutting a suture, blades crossed.After that, blades opened beyond normal range using for procedure.By x-ray, any metal fragments were not found in the abdominal cavity.No injury for the patient has been currently reported.Components in use listed as concomitant devices are: po602r / jaw ins.Micro-dissector sciss 5mm 310mm, pm973r / nsulated outer tube 5/5mm 310mm, po958r / monopolar handle without ratchet.

Manufacturer Narrative

Investigation: the components have been examined visually and microscopically with a keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera.We mad a visual inspection of the instrument.First we investigated the metal inner tube.Here we found a deformed tip.Furthermore we investigated the pull rod with ball.Here we found visible traces of usage.Additionally we made a visual inspection of the joint rod.Here we found a deformation and brown discoloration.We made a visual inspection of the fracture surface and the broken off fragment.Here we found brown and silicate discoloration.Furthermore we made a visual inspection of the main jaw part with scissor blade.Here we found brown discoloration and silicate discoloration.Additionally we found a damaged scissor blade with broken off part.Conclusion and root cause: the root cause of the problem is most probably usage related.Rational: according to the quality standard, a production error or material defect can be excluded.No pores or inclusions could be found on the point of rupture.We assume a mechanical overload situation as the causal factor and these will result in the breakages and damage.We assume that the discoloration and unknown residues or corrosion.We also assume that the silicate discoloration were caused by reprocessing.No capa is necessary.

• Brand Name: JAW INS.MICRO-DISSECTOR SCISS 5MM 310MM
• Type of Device: ENDOSCOPY
• 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: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 7138921
• MDR Text Key: 95619545
• Report Number: 9610612-2017-00630
• Device Sequence Number: 1
• Product Code: KNF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K010752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PO602R
• Device Catalogue Number: PO602R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/21/2017
• Date Manufacturer Received: 12/19/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other