MAUDE Adverse Event Report: INTEGRA YORK, PA INC. MICRO ADSON TISS FCPS 1X2; M5 - GENERAL SURGERY

Catalog Number 17-2500

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, therefore the failure mode cannot be confirmed.Lot number / serial number not received to perform dhr review.A failure analysis and determination of root cause is not possible due to the lack of information received to perform a complete investigation.Product has not been returned.The reported complaint is unconfirmed.Device identifier (b)(4).

Event Description

It was reported that the 17-2500 micro adson tissue forceps lost its ¿teeth¿.The device was in contact with the patient, but no injury noted.It was unknown if there was a surgical delay.Additional information has been requested.

• Brand Name: MICRO ADSON TISS FCPS 1X2
• Type of Device: M5 - GENERAL SURGERY
• 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: 8671622
• MDR Text Key: 147194869
• Report Number: 2523190-2019-00076
• Device Sequence Number: 1
• Product Code: GEN
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2019

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: 17-2500
• Device Lot Number: 901955
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 06/05/2019
• 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