MAUDE Adverse Event Report: AMERICAN CONTRACT SYSTEMS GYN ROBOTIC PACK; LAPAROSCOPY KIT

Model Number	EVRB95H
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the event was not returned for evaluation.A follow-up report will be provided upon conclusion of investigation.American contract system is a convenience kit manufacturer.The complaint component is manufactured by medical action industries part number 731-b4.(registration number: 1030451).The manufacturer has been notified.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or has caused serious injury.
Event or Problem Description
It was reported that blue fibers were found on patient's skin and in the surgical site (abdomen) during surgery.Additional information was received on october 14, 2024, the customer responded the surgery was a robotic hysterectomy.The fibers were irrigated and suctioned from site/skin with no other impact reported.Additional information was requested to get component information from the customer on october 11, 2024, october 14, 2024, and october 15, 2024.
Additional Manufacturer Narrative
The product involved in the event was not returned for evaluation.The manufacturer, jiangsu guanda medical, has responded to supplier corrective action request.The supplier indicated they have no inventory of the component, 731-b4, lot 2402gd27b in warehouse.The retained sample from complaint lot was reviewed, no linting issue was observed.The device history record was reviewed, records were found to be conforming, and product was documented as meeting all specifications prior to release.There is no upward trend for this incident type.The manufacturer has retrained staff on november 11, 2024, on the "folding and finishing" and "organize process inspection" procedures to ensure teammates are appropriately inspecting towels for lint during inspection and folding processes.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or has caused serious injury.

• Brand Name: GYN ROBOTIC PACK
• Common Device Name: LAPAROSCOPY KIT
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS; 2610 ne industrial drive; suite 220; kansas city MO 64120
• Manufacturer (Section G): JIANGSU GUANGDA MEDICAL MATERIAL GROUP CO., LTD.; 18 baochang road north; haian; jiangsu, china NC 28704
• Manufacturer Contact: nichole coggins ; 2610 ne industrial drive; suite 220; kansas city, MO 64120 ; 8287820529
• MDR Report Key: 20580081
• Report Number: 3003419114-2024-00004
• Device Sequence Number: 8003285
• Product Code: FDE
• UDI-Device Identifier: 00191072215130
• UDI-Public: 00191072215130
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EVRB95H
• Device Catalogue Number: EVRB95H
• Device Lot Number: 12-7155711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown