MAUDE Adverse Event Report: INTEGRA YORK, PA INC. ROTO-CAM MARYLAND DISS MONO 5; DISSECTING FORCEPS AND HOOKS

Catalog Number 625126

Device Problems Break (1069); Material Disintegration (1177); Material Fragmentation (1261); Metal Shedding Debris (1804)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/13/2015

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

Initially, risk management called to advise (1) 625126 broke off (the tip) inside a patient during a procedure.(b)(6) customer reports doctor was performing a diagnostic laparoscopy with cholecystectomy.Surgeon was dissecting tissue when the tip broke.All visible pieces were removed with another maryland dissector.Surgeon did visual inspection and irrigation, all pieces thought to have been removed.No x-ray done as surgeon felt all pieces were removed.No obvious harm to the patient.

Manufacturer Narrative

10/28/15 integra investigation completed.Manufacture date unknown.Method: failure analysis, device history evaluation.Results: failure analysis - roto-cam returned in used condition, not showing any unusual markings.The returned roto-cam shows wear, scratched insulation, and a broken tip.During the analysis of the tip, it is noticed that the screw pin got loose and caused the tip to fall out.It appears the instrument is used and not knowing how it was maintained and handled, the cause is undetermined.This type of damage usually is the result from improper usage.Device history evaluation - dhr review was completed with all history available.Nonconforming product report / nonconforming material report history: there are no applicable nonconforming product report / nonconforming material report history.Variance authorization / deviation history: none.Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history.Corrective action preventive action history: none.Health hazard evaluation history: none.Conclusion: the complaint report has been confirmed; the root cause has not been identified as a workmanship or material deficiency.

• Brand Name: ROTO-CAM MARYLAND DISS MONO 5
• Type of Device: DISSECTING FORCEPS AND HOOKS
• 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: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5157819
• MDR Text Key: 28564061
• Report Number: 2523190-2015-00107
• Device Sequence Number: 1
• Product Code: KNF
• Combination Product (y/n): N
• PMA/PMN Number: K932456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 625126
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32 YR