MAUDE Adverse Event Report: INTEGRA YORK, PA INC. MIXTER FCPS 9; CARDIOVASCULAR GENERAL

Catalog Number 140230

Device Problem Degraded (1153)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A customer reported that the 140230 mixter forceps were sterilized (steam autoclaved) and became rusted.There was no patient injury reported and no known surgery delay.

Event Description

N/a.

Manufacturer Narrative

Ud information: (b)(4).The returned forceps was in used condition with brown staining between the blades, potentially due to cleaners containing polyphosphates or high water iron content.The reported complaint was confirmed.Definite root cause could not be determined.Reference the ifu.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• Brand Name: MIXTER FCPS 9
• Type of Device: CARDIOVASCULAR GENERAL
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 10285509
• MDR Text Key: 202046160
• Report Number: 2523190-2020-00074
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/23/2020

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 Catalogue Number: 140230
• Device Lot Number: AB1911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Initial Date Manufacturer Received: 06/23/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 08/11/2020
• Supplement Dates FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1