MAUDE Adverse Event Report: AESCULAP AG MONOPOLAR CABLE W/LG.PIN 12FEET; LAPAROSCOPIC SURGERY

Model Number GK246

Device Problem Mechanical Problem (1384)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with monopolar cable.According to the complaint report: "there had been an incident where a gk246 had malfunctioned and injured a member of staff.Complainant has advised the gk246 has "exploded in a surgeon's hand"; still trying to obtain further information regarding end user situation." the surgeon has an temporary impairment.The adverse event/malfunction is filed under (b)(4).

Manufacturer Narrative

General information: the device was provided contaminated and has been decontaminated by low.Consequences for the patient: temporary damage that will heal fully and will most likely not negatively influence the patient in the future.Investigation: the provided cable is in a used condition, the instrument-plug is broken off.Vigilance investigator carried out the pictorial documentation1 visually and microscopically2.The cable is broken off at the right behind the plug of the instrument side.The fracture pattern shows signs of a fatigue fracture, the braids are pressed due to repeated tumbling movement or bend of the cable near the broken plug.The manufacturer has tested the product and verified that its insulation can withstand 200 reprocessing cycles.In clinical practice, the service life will depend on the individual intraoperative usage and the hospital's specific reprocessing conditions.Batch history review: the traceability of articles without batch management requirement is guaranteed by the production order number, which can be traced over the production period and the corresponding customer (backtrack).In addition, the raw materials, semi-finished parts, etc.Used for the order are documented in the manufacturing history records (dhr - device history records).This ensures the traceability of the internal supply and production chain.Internal traceability is thus guaranteed.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage.Rationale: the breakage of the cable was most likely caused by a fatigue fracture, most likely due to improper handling, e.G.Repeated tumbling movement or bend of the cable near the broken plug.Corrective action: according to sop sa-de13-m-4-2-04-000-0 (corrective action and preventive action), a capa is not necessary.

• Brand Name: MONOPOLAR CABLE W/LG.PIN 12FEET
• Type of Device: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9732848
• MDR Text Key: 181642039
• Report Number: 9610612-2019-00962
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• PMA/PMN Number: K770428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GK246
• Device Catalogue Number: GK246
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention