MAUDE Adverse Event Report: AESCULAP AG ATR.FORCEPS INSULATED 300MM; HF INSTRUMENTS MONOPOLAR

Model Number BD860R

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Date 07/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Preliminary investigation: at the time of this report, the article was not yet available for investigation.According to the available information the product affected will be available for investigation.After completion of the failure analysis we will send you a final report unsolicited.Without the product an exact cause cannot be determined at this moment.Based on the information available the root cause is most probably usage related due to improper handling or an overload situation.According to the quality standard, a material defect and production error can be excluded.For further investigations, the product is required for examination.A review of the quality and manufacturing history records is not possible because the lot number is unknown.

Event Description

It was reported that there was an issue with atr.Forceps insulated 300 mm.According to the complaint description: "reason for use: coagulation and dissection tissues during rectum resection.Contact with the patient was about 60 minutes.During dissection of the meso-rectum, colour transmission through coated clamp, with defect of shielding (not visible at the inspection.Insufficient shielding?)." an additional medical intervention was necessary.The adverse event / malfunction is filed under aag reference (b)(4).

• Brand Name: ATR.FORCEPS INSULATED 300MM
• Type of Device: HF INSTRUMENTS MONOPOLAR
• 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: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8915769
• MDR Text Key: 155053417
• Report Number: 9610612-2019-00582
• Device Sequence Number: 1
• Product Code: HTD
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BD860R
• Device Catalogue Number: BD860R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention