MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX; CLIP, IMPLANTABLE

Model Number CA500

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/21/2022

Event Type  malfunction  

Event Description

Procedure performed: "colectomy".Event description: complaint # (b)(4) created based on medwatch # (b)(4) received via email on 08nov2022."[name] doesn't know much but he said that there was fluid coming out of the handle and the operating room staff said it looked like oil.Spoke with customer (or nurse [name]) and she said, product was only opened in or room before patient arrived, scrub nurses realized there was oil all on it and opened a new ca500 from different lot number.Product was not used in any case or person.Customer is curious if this is happening to all of these clip appliers with the same lot number.Damaged product was not used in case, new ca500 with different lot number was used and worked fine." product is available for return.Additional information was received via email on 04nov2022 from [name], account manager, applied medical the fluid was "clear oily liquid" that was extremely viscus".The fluid was found after opening the packaging.Additional information was received via medwatch # (b)(4) on 08nov2022.The intended procedure was a colectomy."the handle of device was leaking an oily substance onto the surgeon¿s hand and the field.Two of these were opened with the same issue (same lot#).Surgeons¿ gloves were changed, and item removed from field.No harm to patient.Another clip applier was opened (different lot#) without issue." patient status: "no harm to patient".Intervention: "another clip applier was opened (different lot#) without issue".

Manufacturer Narrative

The event unit is anticipated to return to applied medical.A follow up report will be provided following the completion of the investigation.This report is to follow-up medwatch # (b)(4).

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.The complainant¿s experience could not be confirmed as there was no excessive lubricant found during visual inspection of the returned unit.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event or confirm that a product malfunction occurred.This event is not reportable as it is unlikely to cause or contribute to death or serious injury.This report is to follow up medwatch report # (b)(4).

Event Description

Procedure performed: "colectomy".Event description: complaint #(b)(4) created based on medwatch #(b)(4) received via email on 08nov2022."[name] doesn't know much but he said that there was fluid coming out of the handle and the or staff said it looked like oil.Spoke with customer (or nurse [name]) and she said, product was only opened in or room before patient arrived, scrub nurses realized there was oil all on it and opened a new ca500 from different lot number.Product was not used in any case or person.Customer is curious if this is happening to all of these clip appliers with the same lot number.Damaged product was not used in case, new ca500 with different lot number was used and worked fine." product is available for return.Additional information was received via email on 04nov2022 from [name], account manager, (b)(4).The fluid was "clear oily liquid" that was extremely viscus".The fluid was found after opening the packaging.Additional information was received via medwatch #(b)(4) on 08nov2022.The intended procedure was a colectomy."the handle of device was leaking an oily substance onto the surgeon¿s hand and the field.Two of these were opened with the same issue (same lot#).Surgeons¿ gloves were changed, and item removed from field.No harm to patient.Another clip applier was opened (different lot#) without issue." patient status: "no harm to patient".Intervention: "another clip applier was opened (different lot#) without issue".

• Brand Name: CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 15838694
• MDR Text Key: 307986380
• Report Number: 2027111-2022-00831
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)250714(30)01(10)1459348
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CA500
• Device Catalogue Number: 101474072
• Device Lot Number: 1459348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female