MAUDE Adverse Event Report: AESCULAP AG ATR.FORCEPS INSULATED 300MM; GENERAL SURGICAL INSTRUMENTS

Model Number BD860R

Device Problems Electrical /Electronic Property Problem (1198); Grounding Malfunction (1271)

Patient Problems Burn(s) (1757); Patient Problem/Medical Problem (2688)

Event Date 05/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).No product at hand.Batch history review: the product does not require batch management; a review of the device quality and manufacturing history records is not possible.Conclusion and root cause: 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.Three is the possible that the root cause of the problem is most probably usage related.Rationale: according to the quality standard a material defect and production error can be excluded.Without the product we cannot determine the exact cause.There is the possible for a usage error due to improper handling.Due to the statement of the customer, "missing shielding of the pincers caused the burn of the tissue", here is the possibility that the tissue was burnt with the surfaces which are free of coatings.If further investigation are required, the product should be provided for examination.No capa necessary.

Event Description

It was reported the tissue burned intraoperatively.The reporter indicated that during surgery for pathology oncology of the rectum, the surgeon was using the monopolar forceps to dissect and coagulate.Per the reporter, "missing shielding of the pincers caused the burn of the tissue." consequences: medical surgery.Additional information has been requested, however, not yet received.

• Brand Name: ATR.FORCEPS INSULATED 300MM
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• 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: lindsay chromiak ; 3773 corporate parkway; center valley, PA 18034 ; 8002581946
• MDR Report Key: 8729165
• MDR Text Key: 149061460
• Report Number: 9610612-2019-00411
• 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: 06/24/2019

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?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/14/2019
• Initial Date Manufacturer Received: 05/29/2019
• Initial Date FDA Received: 06/24/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR