MAUDE Adverse Event Report: INTEGRA YORK, PA INC. TISCHLEY BPSY FCPS 9-1/4IN WITH LOCK; PFM07

Catalog Number 301442WL

Device Problems Sticking (1597); Difficult to Open or Close (2921); Insufficient Information (3190)

Patient Problems Discomfort (2330); No Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2015

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

Customer initially reports device was sticking in place during procedures.(b)(6) 2015 customer reports that - "our first time using the new tischler, doctor tried to biopsy patient.The forcep would not clamp down and he was unable to get a good biopsy because he couldn't separate the tissue from the cervix.Doctor had to manually open the tischler with the handle and another tischler was used for the biopsy.The device will not open on its own.It was uncomfortable for the patient during the process.

Manufacturer Narrative

On 11/11/2015 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - failure analysis cannot be completed due to the lack of information received to perform a complete investigation.Product has not been returned for evaluation.Device history evaluation - dhr review.Nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report / nonconforming material report history.Variance authorization / deviation history: there is no applicable variance authorization / deviation history.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: root cause cannot be determined due to the lack of information received to perform a complete investigation.Product has not been returned for evaluation.

• Brand Name: TISCHLEY BPSY FCPS 9-1/4IN WITH LOCK
• Type of Device: PFM07
• 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; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5089090
• MDR Text Key: 26438203
• Report Number: 2523190-2015-00094
• Device Sequence Number: 1
• Product Code: HFB
• 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: Nurse
• Type of Report: Followup
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 301442WL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 31 YR