MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR MICROSENSOR PLASTIC BOLT KT R; ICP MICROSENSORS (ROHS)

Catalog Number 626632

Device Problem Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 07/23/2022

Event Type  malfunction  

Event Description

A facility reported a microsensor (id 626632) would not recognize the connection and monitor kept reading "no microsensor detected".The procedure was completed with a replacement product available.No patient injury was reported.

Manufacturer Narrative

The microsensor (id 626632) was not returned for evaluation (discarded by customer) and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined; however, the possible root cause for this issue reported by the customer could be due to excessive pressure applied to product.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: MICROSENSOR PLASTIC BOLT KT R
• Type of Device: ICP MICROSENSORS (ROHS)
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15710910
• MDR Text Key: 307263999
• Report Number: 3013886523-2022-00498
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K153347
• 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: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 626632
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2022
• 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