MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT CORE TRUMPET 5X32CM; CATHETER, PERITONEAL

Model Number CD8190

Device Problems Activation, Positioning or Separation Problem (2906); Patient Device Interaction Problem (4001); Physical Resistance/Sticking (4012)

Patient Problems Injury (2348); Blood Loss (2597)

Event Date 02/25/2020

Event Type  Injury  

Manufacturer Narrative

The investigation of the reported complaint that the suction button was stuck and caused bleeding is inconclusive.The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not be verified, root cause could not be identified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment and found no abnormalities that would contribute to this issue.A two-year lot history review shows this is the only complaint for this lot number and failure mode.A two-year review of complaint history for this device family and failure mode, revealed there has been a total of 44 complaints, regarding 67 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.0001.The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Per the ifu the user is also advised that procedures for endoscopic surgery should be performed only by qualified and trained physicians familiar with endoscopic surgical technique.Additionally, conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

On behalf of the customer, the distributor reported an issue with the core trumpet 5 x 32cm, item # cd8190, lot 201905244 that occurred (b)(6) 2020 during an unknown gynecological procedure.It was reported that the "suction/ irrigation product's suction button got stuck so that suction continues even though the button itself is released.First instrument stayed in continuous suction, so a new core instrument was needed.The second one also got stuck to continuous suction.The bowel sucked inside to the instruments inner lumen simultaneously with the fatty tissue closed the distal tubing holes outside from the instrument.The suction device was shut down and the instrument released.The bowel was heavily stuck inside the core instrument.Bleeding from the bowel outer layer was controlled some minutes after the incident." it is indicated the procedure was successfully completed with a delay, length of time not made available.Additional information obtained clarified that the lot numbers of both devices mentioned and used were the same, lot 201905224.During the first quarter of the procedure, while the device setting was 12mmhg, it was reported that as the suction continued, part of the bowel touched the tip on the instrument at the same time some fatty tissue closed the instrument's tip sidewall holes.This resulted in the bowel being sucked deeper inside the instrument's lumen.There was no visable clogging inside the tubing prior to the incident.The device was irrigated to try to remove the clog, but did not help release the tissue.The device was being clogged by both fatty tissue and a piece of the bowel.As the suction unit was shut down, it was possible to release instrument from the surrounding tissue.The bleeding was on the bowel's upper layer so the decision was made to wait for some minutes, not to do anything else but watch if it would stop bleeding.It looked like it would therefore they did not clip it or suture it or use any hemostasis.It was confirmed the patient is presumed to be in good condition.This reporting is being raised as an injury due to the patient's upper layer of bowel bleeding.

Event Description

On behalf of the customer, the distributor reported an issue with the core trumpet 5x32cm, item # cd8190, lot 201905244 that occurred (b)(6) 2020 during an unknown gynecological procedure.It was reported that the "suction/irrigation product's suction button got stuck so that suction continues even though the button itself is released.First instrument stayed in continuous suction, so a new core instrument was needed.The second one also got stuck to continuous suction.The bowel sucked inside to the instruments inner lumen simultaneously with the fatty tissue closed the distal tubing holes outside from the instrument.The suction device was shut down and the instrument released.The bowel was heavily stuck inside the core instrument.Bleeding from the bowel outer layer was controlled some minutes after the incident." it is indicated the procedure was successfully completed with a delay but length of time not made available.Additional information obtained clarified that the lot numbers of both devices mentioned and used were the same, lot 201905244.During the first quarter of the procedure, while the device setting was 12mmhg, it was reported that as the suction continued, part of the bowel touched the tip on the instrument at the same time some fatty tissue closed the instrument's tip sidewall holes.This resulted in the bowel being sucked deeper inside the instrument's lumen.There was no visible clogging inside the tubing prior to the incident.The device was irrigated to try to remove the clog but did not help release the tissue.The device was being clogged by both fatty tissue and a piece of the bowel.As the suction unit was shut down, it was possible to release instrument from the surrounding tissue.The bleeding was on the bowel's upper layer so the decision was made to wait for some minutes, not to do anything else but watch if it would stop bleeding.It looked like it would therefore they did not clip it or suture it or use any hemostasis.It was confirmed the patient is presumed to be in good condition.This reporting is being raised as an injury due to the patient's upper layer of bowel bleeding.

Manufacturer Narrative

Please note the previously submitted b5 read: on behalf of the customer, the distributor reported an issue with the core trumpet 5x32cm, item # cd8190, lot 201905244 that occurred (b)(6) 2020 during an unknown gynecological procedure.It was reported that the "suction/irrigation product's suction button got stuck so that suction continues even though the button itself is released.First instrument stayed in continuous suction, so a new core instrument was needed.The second one also got stuck to continuous suction.The bowel sucked inside to the instruments inner lumen simultaneously with the fatty tissue closed the distal tubing holes outside from the instrument.The suction device was shut down and the instrument released.The bowel was heavily stuck inside the core instrument.Bleeding from the bowel outer layer was controlled some minutes after the incident." it is indicated the procedure was successfully completed with a delay, length of time not made available.Additional information obtained clarified that the lot numbers of both devices mentioned and used were the same, lot 201905224.During the first quarter of the procedure, while the device setting was 12mmhg, it was reported that as the suction continued, part of the bowel touched the tip on the instrument at the same time some fatty tissue closed the instrument's tip sidewall holes.This resulted in the bowel being sucked deeper inside the instrument's lumen.There was no visable clogging inside the tubing prior to the incident.The device was irrigated to try to remove the clog, but did not help release the tissue.The device was being clogged by both fatty tissue and a piece of the bowel.As the suction unit was shut down, it was possible to release instrument from the surrounding tissue.The bleeding was on the bowel's upper layer so the decision was made to wait for some minutes, not to do anything else but watch if it would stop bleeding.It looked like it would therefore they did not clip it or suture it or use any hemostasis.It was confirmed the patient is presumed to be in good condition.This reporting is being raised as an injury due to the patient's upper layer of bowel bleeding.The corrected b5 being submitted today reads: on behalf of the customer, the distributor reported an issue with the core trumpet 5x32cm, item # cd8190, lot 201905244 that occurred (b)(6) 2020 during an unknown gynecological procedure.It was reported that the "suction/irrigation product's suction button got stuck so that suction continues even though the button itself is released.First instrument stayed in continuous suction, so a new core instrument was needed.The second one also got stuck to continuous suction.The bowel sucked inside to the instruments inner lumen simultaneously with the fatty tissue closed the distal tubing holes outside from the instrument.The suction device was shut down and the instrument released.The bowel was heavily stuck inside the core instrument.Bleeding from the bowel outer layer was controlled some minutes after the incident." it is indicated the procedure was successfully completed with a delay but length of time not made available.Additional information obtained clarified that the lot numbers of both devices mentioned and used were the same, lot 201905244.During the first quarter of the procedure, while the device setting was 12mmhg, it was reported that as the suction continued, part of the bowel touched the tip on the instrument at the same time some fatty tissue closed the instrument's tip sidewall holes.This resulted in the bowel being sucked deeper inside the instrument's lumen.There was no visible clogging inside the tubing prior to the incident.The device was irrigated to try to remove the clog but did not help release the tissue.The device was being clogged by both fatty tissue and a piece of the bowel.As the suction unit was shut down, it was possible to release instrument from the surrounding tissue.The bleeding was on the bowel's upper layer so the decision was made to wait for some minutes, not to do anything else but watch if it would stop bleeding.It looked like it would therefore they did not clip it or suture it or use any hemostasis.It was confirmed the patient is presumed to be in good condition.This reporting is being raised as an injury due to the patient's upper layer of bowel bleeding.It was indeed confirmed that the lot numbers of both devices mentioned and used were the same, lot 201905244 (not 201905224).All other information previously submitted, including product information, remains unchanged and correct.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: CORE TRUMPET 5X32CM
• Type of Device: CATHETER, PERITONEAL
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, mexico 31136 ; MX 31136
• MDR Report Key: 9890877
• MDR Text Key: 196639991
• Report Number: 3007305485-2020-00107
• Device Sequence Number: 1
• Product Code: GBW
• UDI-Device Identifier: 10653405046219
• UDI-Public: (01)10653405046219(17)240522(10)201905244
• Combination Product (y/n): N
• PMA/PMN Number: K926477
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 04/17/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2024
• Device Model Number: CD8190
• Device Catalogue Number: CD8190
• Device Lot Number: 201905244
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2020
• Initial Date FDA Received: 03/27/2020
• Supplement Dates Manufacturer Received: 04/16/2020
• Supplement Dates FDA Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other