MAUDE Adverse Event Report: INTEGRA YORK, PA INC. MALIK CYSTIC DUCT 8-1/2; M4 - ABDOMINAL

Catalog Number 14-69

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 11/06/2018

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

It was reported by a customer that on (b)(6) 2018, a 14-69 malik cystic duct had some residue or substance around the lockbox area.The product was not in contact with the patient.No patient injury or death alleged, and the event did not lead to increase the surgery time.No other clinical information received.Additional information had been requested.

Event Description

N/a.

Manufacturer Narrative

The device was returned to the manufacturer for physical evaluation, therefore the failure mode was confirmed.An investigation of the device manufacturing records was conducted by the manufacturer.The returned forceps are new without the original packaging.The product identification markings have been removed/neutralized, per the customer's request.The residue is a result of the compound and buffing material used during the neutralization process.The residue is easily removed with a soft cloth.Manual surgical instruments, unless otherwise noted, are sold non-sterile and require thorough cleaning, disinfecting, and sterilizing prior to use.

• Brand Name: MALIK CYSTIC DUCT 8-1/2
• Type of Device: M4 - ABDOMINAL
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 8117051
• MDR Text Key: 129459611
• Report Number: 2523190-2018-00172
• Device Sequence Number: 1
• Product Code: FFN
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-69
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1