MAUDE Adverse Event Report: AESCULAP AG BULLET NOSE GRASPER 5MM 310MM; AE 02 504 19A

Model Number PO190R

Device Problems Break (1069); Overheating of Device (1437)

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

Event Date 09/28/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: usa.It was reported that the handle broke during normal operation.Insulation shaft melted.No harm to the patient.There was a fifteen (15) minute delay in surgery.

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 instrument.Here we found visible damage and scratches.Additionally we found unknown deposits.Furthermore we found a broken off flexible handle part.We made a visual inspection of the fracture surface.We also made a visual inspection of the broken off handle piece without lock po958821.Additionally we made a visual inspection of the fracture surface.The instrument could not be disassembled due to the damages and we found no signs of a melted insulation shaft.Conclusion and root cause: the root cause of the problem is most probably usage related.Rational: according to the quality standard, a material defect or production error can be excluded.No pores or foreign bodies could be found on the point of rupture.We assume an improper handling during assembling due to the visible damage of the outer tube as causal factor.We assume that the outer tube was compressed and these will result in the visible damage.We also assume that the breakage of the handle was caused due to a mechanical overload situation during assembling.No capa is necessary.

• Brand Name: BULLET NOSE GRASPER 5MM 310MM
• Type of Device: AE 02 504 19A
• 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
• MDR Report Key: 6978206
• MDR Text Key: 90965325
• Report Number: 9610612-2017-00503
• Device Sequence Number: 1
• Product Code: KNF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/30/2018

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 Model Number: PO190R
• Device Catalogue Number: PO190R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/05/2017
• Initial Date Manufacturer Received: 09/29/2017
• Initial Date FDA Received: 10/25/2017
• Supplement Dates Manufacturer Received: 09/29/2017
• Supplement Dates FDA Received: 07/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other