MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN SURGSTRP11/2X6-200; SURGICAL STRIPS

Catalog Number	801454
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
A facility reported a piece of the x-ray wire of a surgical strip (id 801454) has fallen off inside the patient's abdomen during a laparoscopic hemicolectomy and could not be recovered.It was not visible in x-ray.The event led to a minor surgical delay.
Additional Manufacturer Narrative
Additional information received: "the x-ray wire could not be recovered by sight.An x-ray overview was made where the wire could not be seen either.".
Additional Manufacturer Narrative
Surgical strip was not returned for evaluation; however, a photo was provided: dhr - the batch records were reviewed for any anomalies or ncs related to the finished device, and none were identified.Failure analysis - review of the image confirms a portion of the x-ray strip missing from the body of the surgical strip.Root cause - review of the image confirms a portion of the x-ray strip missing from the body of the surgical strip.A potential contributor to the x-ray strip separation may be related to the welding attachment process, during production.A corrective and preventative action (capa) was closed in august 2024 for the patties/strips product family related to x-ray polymer issues, string issues and incorrect count.Actions were implemented to minimize the issues.

• Brand Name: CODMAN SURGSTRP11/2X6-200
• Common Device Name: SURGICAL STRIPS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20080078
• Report Number: 3014334038-2024-00180
• Device Sequence Number: 12662298
• Product Code: HBA
• UDI-Device Identifier: 10381780515104
• UDI-Public: 10381780515104
• Combination Product (Y/N): N
• PMA/510(K) Number: K880402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 801454
• Device Lot Number: 6989840
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 09/05/2024; 09/26/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 09/20/2024; 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown