MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN 11MM DISPOSBL PERFORATR; DISPOSABLE PERFORATORS

Model Number 261222

Device Problem Peeled/Delaminated (1454)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A facility reported the label of a perforator (id 261222) came off during use and thus fall in the wound.No patient injury.The procedure was delayed cause they had to search for the pieces of paper in the body of patient but there is no information about exact time.

Manufacturer Narrative

The perforator was returned for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - a visual inspection utilizing the unaided eye performed.Unit had light soiling and a partially worn label but showed no other observable anomalies.Spring test attempted: unit felt slightly "sticky" when rotating the hudson end but was freed by drilling 5 test holes.Once freed, the unit passed the spring test and functioned as designed.Functional test performed: unit had slight difficulty rotating "as received" but the unit was freed by drilling 5 test holes.Once freed the unit functioned as designed and successfully drilled 5 holes with no issues.Because the unit was returned with a worn/damaged eto label the complaint condition could be confirmed.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was received for analysis and the analyst could confirm the complaint condition.

• Brand Name: CODMAN 11MM DISPOSBL PERFORATR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16635722
• MDR Text Key: 312284639
• Report Number: 3014334038-2023-00038
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 10381780513605
• UDI-Public: 10381780513605
• Combination Product (y/n): N
• PMA/PMN Number: K071931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2023

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 Model Number: 261222
• Device Catalogue Number: 261222
• Device Lot Number: 6899455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 05/09/2023
• Supplement Dates FDA Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2023
• 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