MAUDE Adverse Event Report: RAYNHAM CODMAN SURG STRP1/2X6-200; SURGICAL STRIPS

Model Number	801451
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported a surgical strip (id 801451) disconnected from the rest during a laparoscopic excision of endometriosis procedure.The surgical strip was used and removed from the patient and when staff was irrigating the area a nurse noted a piece floating in patient's abdomen.The product was not altered or cut from the original size and was not soaked nor irrigated prior to use.No patient injury reported and it is unknown if the event led to surgical delay.
Additional Manufacturer Narrative
The device involved in the reported incident is not available for evaluation.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
N/a.
Additional Manufacturer Narrative
The surgical strip (id 801451) was not returned for evaluation as the product is not available for return as per customer; therefore, an evaluation of the device could not be performed.A photo of the piece that came off was provided, however without the product returned it is not possible to determine whether the product meets specification.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.Even though root cause is not confirmed, the customer reported that the strip was not moistened prior to use.The ifu for this product instructs the user to always moisten the patties/strips prior to use on patient tissue.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: CODMAN SURG STRP1/2X6-200
• Common Device Name: SURGICAL STRIPS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14162018
• Report Number: 3014334038-2022-00081
• Device Sequence Number: 20272660
• Product Code: HBA
• UDI-Device Identifier: 10381780515074
• UDI-Public: 10381780515074
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2022

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 Expiration Date: 03/31/2026
• Device Model Number: 801451
• Device Catalogue Number: 801451
• Device Lot Number: 5416112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 05/19/2022
• Date Device Manufactured: 04/01/2021
• 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