MAUDE Adverse Event Report: AESCULAP AG ATR.UNI.FIX FORCEPS W/GROOVES D:5/310MM; LAPAROSCOPIC SURGERY

Model Number PO235R

Device Problem Defective Component (2292)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

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 the forceps.According to the complaint description, the grip on the fenestrated grasper was not strong enough to grasp tissue.This caused the surgeon to tear a patient´s stomach.The procedure was a nissen fundoplication/ laparoscopic nissen.An additional medical intervention was necessary.Sutures were required and there was no detrimental harm (to be clarified).Patient was stable.Additional information has been requested but not yet received as of this report.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

General information we received a complaint about an atraumatic universal forceps.Up to now, the product is not available for investigation.Consequences for the patient intra-operative medical intervention was necessary.Investigation up to now, the product is not available for investigation.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: without the product, an exact cause cannot be determined at this moment.Due to the constant monitoring of the compliance with our quality standards, as matters stand, a production or material defect can most likely be excluded.Therefore, the root cause of the error is most probably usage related.For further investigations, the product is required for examination.Rationale: according to the quality standard, a material defect and production error can be excluded.A usage related error cannot be excluded, e.G.Due to improper handling or an overload situation.Prior to each use, the devices must be inspected for loose, bent, broken, cracked, worn, or fractured components.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: ATR.UNI.FIX FORCEPS W/GROOVES D:5/310MM
• Type of Device: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9898195
• MDR Text Key: 186210590
• Report Number: 9610612-2020-00085
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K940936
• 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: 06/15/2020

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: PO235R
• Device Catalogue Number: PO235R
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 05/28/2020
• Supplement Dates FDA Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention