MAUDE Adverse Event Report: INTEGRA YORK, PA INC. FORCEPS MCL-S21 RIGHT SATALOFF HEART; PFM11

Catalog Number MCL-S21

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 10/26/2017

Event Type  Injury  

Manufacturer Narrative

Integra has completed their internal investigation on november 15, 2017.Results: evaluation of returned device; during the analysis of the returned used forceps, it is noticed that the tips is broken, without knowing how the instrument was used during use, the cause is undetermined.The complaint report is confirmed; damaged worn.Dhr review: no anomalies that could be associated with the complaint were observed.Complaints history: no adverse trend - first occurrence of this risk for this device.Conclusion: there were forceps, returned used/processed, showing wear and a broken tip.The complaint report has been confirmed.The root cause has not been identified as a workmanship or material deficiency.

Event Description

It was reported that the tip of the instrument broke in patient's airway during surgical procedure.Surgeon was able to retrieve the broken piece.Patient injury was reported and medical intervention was required.The event lead to surgical delay, it is unknown for how long.Additional information has been requested.

• Brand Name: FORCEPS MCL-S21 RIGHT SATALOFF HEART
• Type of Device: PFM11
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7046122
• MDR Text Key: 92549101
• Report Number: 2523190-2017-00145
• Device Sequence Number: 1
• Product Code: KAE
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MCL-S21
• Device Lot Number: 140901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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