MAUDE Adverse Event Report: AESCULAP AG DISP.METZENBAUM SCISSORS D:5/310MM; ENDOSCOPY

Model Number PO840SU

Device Problem Break (1069)

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

Event Date 11/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

(b)(6).During an intervention: partial gastrectomy under ceolioscopy, we used ceolio monopolar scissors.But after 3 hours of intervention, the surgeon by changing places, using the scissors connected to the monopolar cable, found that the tip of the scissors to connect the mono cable to the scissors was broken.

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 made a visual inspection of the hf-pin.Here we found a broken off tip.Additionally, we made a visual inspection of the fracture surface.Batch history review: the device quality and manufacturing history records have been checked for the lot number and found to be according to the specification, valid at the time of production.Conclusion and root cause: the root cause of the problem is most probably usage related.Rational: according to the quality standards and dhr files a material defect or production error can be excluded.No pores, inclusions or foreign bodies could be found on the point of rupture.Additionally, according to the report of the quality assurance division, the instrument shows signs of external force.We assume a mechanical overload situation as the causal factor.No capa is necessary.

• Brand Name: DISP.METZENBAUM SCISSORS D:5/310MM
• 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: 7106521
• MDR Text Key: 94515367
• Report Number: 9610612-2017-00608
• Device Sequence Number: 1
• Product Code: KNF
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/21/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: PO840SU
• Device Catalogue Number: PO840SU
• Device Lot Number: 52355186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/05/2017
• Device Age: 4 MO
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 12/11/2017
• Supplement Dates Manufacturer Received: 11/20/2017
• Supplement Dates FDA Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other