MAUDE Adverse Event Report: INTEGRA YORK, PA INC. ULTRA-COAT KERRISON SPURLING 40D UP 9 5MM

Catalog Number RB5975

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 02/18/2019

Event Type  malfunction  

Manufacturer Narrative

The product was returned for evaluation.There was one ultra-coat kerrison returned used/processed showing wear.The tests/measurement used is the visual/card stock method.There was no sticking observed, and the product cut the card stock a tip-mid cut-full cut.The complaint is unconfirmed.The product tested within specifications.Device identifier (b)(4).Linked to mfr report number 2523190-2019-00037.

Event Description

2 of 2 reports.A customer reported that on (b)(6) 2019, the rb5975(lp), ultra-coat kerrison spurling 40d up 9 5mm was ¿sticking bad ¿during a neuro procedure.A 30-minute delay due to the product problem was reported, however there was no patient adverse consequence / or injury reported.The action that was taken after the product problem occurred was that a different size was given to the doctor from the same set.No other clinical information provided.

• Brand Name: ULTRA-COAT KERRISON SPURLING 40D UP 9 5MM
• Type of Device: ULTRA-COAT
• 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: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8411672
• MDR Text Key: 138530604
• Report Number: 2523190-2019-00038
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• PMA/PMN Number: K150428
• 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: 02/18/2019

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: RB5975
• Device Lot Number: 081015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Manufacturer Received: 02/18/2019
• Initial Date FDA Received: 03/12/2019
• 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