MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA LAPO-CLAMP II; SURGICAL RETRACTOR

Catalog Number 3900

Device Problem Separation Problem (4043)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A facility reported that one piece of the lapo-clamp ii (3900) fell off during surgery and onto the patient.All parts were recovered.The broken component was replaced to finish the case.The event did not lead to patient injury; however, an unspecified delay in surgery was reported.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

The suspected lapo-clamp ii (3900) was not returned for evaluation and lot number has not been provided; therefore, an evaluation of the device nor review of the device history record (dhr) could not performed.A possible root cause of a piece falling off during surgery could be use error, however this is unable to be confirmed without being able to evaluate the piece that allegedly fell off during surgery.The root cause, therefore could not be determined.If additional relevant information becomes available, this complaint will be reopened and respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: LAPO-CLAMP II
• Type of Device: SURGICAL RETRACTOR
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15461694
• MDR Text Key: 300729907
• Report Number: 3004608878-2022-00191
• Device Sequence Number: 1
• Product Code: FFO
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2022
• 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