MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CNB10, GELPOINT PATH WITH ISB, 4CM; ANOSCOPE AND ACCESSORIES

Model Number	CNB10
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: tatme case.Hospital: [name] gelpoint point path was used for a tatme case.During the case, surgeon tried to remove a grasper from the 10mm sleeve, it also drags out the plastic instrument guide.A 4th piece was introduced.Half way through the surgery, the surgeon tried to remove the grasper again for cleaning but the plastic instrument guide was dragged out again.In the end, circulating nurse had to open another piece of sleeves from [name] (new box).Additional information received via email on 06apr2021 from [name]: patient status: no patient injury.Type of intervention: a new piece was opened.
Additional Manufacturer Narrative
A sleeve from the event unit was returned to applied medical for evaluation.Visual inspection of the returned unit confirmed that the shield, an internal plastic component of the seal, had separated from the seal.Engineering also observed scratches on the shield and a tear on the septum, an internal rubber component of the seal.Based on condition of the returned unit, it is likely that the reported event was caused by non-axial insertion or removal of asymmetrical instrumentation through the sleeve.Applied medical¿s instructions for use (ifu) states that, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing.".
Event or Problem Description
Name of procedure being performed: tatme case.Describe event or problem: hospital: [name].Gelpoint point path was used for a tatme case.During the case, surgeon tried to remove a grasper from the 10mm sleeve, it also drags out the plastic instrument guide.A 4th piece was introduced.Half way through the surgery, the surgeon tried to remove the grasper again for cleaning but the plastic instrument guide was dragged out again.In the end, circulating nurse had to open another piece of sleeves from [name] (new box).Additional information received via email on 06apr2021 from [name]: plastic instrument guide is "referring to the trocars as per attached picture." photo attached.Patient status: no patient injury.Type of intervention: a new piece was opened.

• Brand Name: CNB10, GELPOINT PATH WITH ISB, 4CM
• Common Device Name: ANOSCOPE AND ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 11717033
• Report Number: 2027111-2021-00463
• Device Sequence Number: 11768851
• Product Code: FER
• UDI-Device Identifier: 00607915137915
• UDI-Public: (01)00607915137915(17)230316(30)01(10)1384246
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K171701
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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: 03/16/2023
• Device Model Number: CNB10
• Device Catalogue Number: 101472124
• Device Lot Number: 1384246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GRASPER