MAUDE Adverse Event Report: AESCULAP AG CERAMIC ELECTRODE TIP L-HK F/GK372R; ENDOSCOPIC ELECTROSUR...

Model Number GK384R

Device Problem Crack (1135)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event: unknown.The product does not require batch management; a review of the device quality and manufacturing history records is not possible.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.Due to a lack of data and without the product we cannot determine the exact cause.According to the quality standard a material defect and production error can be excluded.Due to the statement of the customer: "no defect, the issue was due to product usage as it is a re-usable product." there is the possibility for an usage error.The crack could have been caused due to an improper handling by a mechanical overload situation.There is also the possibility for pre-damage or similar due to previous surgeries.

Event Description

It was reported by the healthcare professional "during a laparoscopic cholecystectomy procedure it was noticed that the diathermy hook was cracked along the back.The covering of the reusable hook was split but did not break off and the hook did not break.The surgeon stopped using the instrument and the instrument was replaced.There was no harm or injury to the patient.No delay in surgery.It was reported the product was ok at the start of the procedure but half way through was when it was noticed that the hook was more exposed than normal.Crack/split was identified." no patient injury / harm reported.No delay in surgery reported.

• Brand Name: CERAMIC ELECTRODE TIP L-HK F/GK372R
• Type of Device: ENDOSCOPIC ELECTROSUR...
• 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: 8294854
• MDR Text Key: 136987388
• Report Number: 9610612-2019-00043
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K970541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2019

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: GK384R
• Device Catalogue Number: GK384R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/23/2019
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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