MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX; LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Model Number CB030

Device Problem Dull, Blunt (2407)

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

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation and no lot # has been provided to manufacturer.A final report will be sent once the results have been analyzed.

Event Description

Procedure performed: lap cases.The facility, including the surgeon who uses the scissors most frequently, has been complaining of dullness of the blades.Not getting a clean cut of the tissue, in some cases having to do multiple squeezes to cut the tissue.No patient injury.No negative clinical outcomes.The complaint involves multiple scissors.The lot numbers and number of products involved is currently unknown.The facility has saved at least one complaint product at this time.This product is available for return.Additional information received via email on 04mar2021 from applied medical account manager i: "the account knows they had dullness issues with our scissors from various lot numbers, but did not keep track of which and when.They also didn¿t note what lot number the one unit from a case that they kept to send us had." additional information received via email on 05mar2021 from applied medical account manager i: [name] received additional information from [name], [name].The facility first began to experience this issue about 2 months ago."2 or 3" devices had this issue with poor cutting function and 3 cases were affected.All of the cases were "lap cases".[name] does not remember the dates of the procedures.The affected lot numbers are unknown.The poor cutting function issues were noted from the beginning of the case.No information has been provided regarding the tissue being cut when the issues were noted."we also got confirmation that they do not reprocess any applied products." two additional complaints have been created to document the three cases affected.The facility will be returning one event unit of unknown lot and multiple sterile units of different lot numbers.The products will be returned under complaint #(b)(4).Intervention: multiple squeezes by the scissors were used to cut the target tissues.Patient status: no patient injury.No negative clinical outcomes.

Event Description

Type of procedure performed: lap cases.The facility, including the surgeon who uses the scissors most frequently, has been complaining of dullness of the blades.Not getting a clean cut of the tissue, in some cases having to do multiple squeezes to cut the tissue.No patient injury.No negative clinical outcomes.The complaint involves multiple scissors.The lot numbers and number of products involved is currently unknown.The facility has saved at least one complaint product at this time.This product is available for return.Additional information received via email on 04mar2021 from [name] "the account knows they had dullness issues with our scissors from various lot numbers, but did not keep track of which and when.They also didn't note what lot number the one unit from a case that they kept to send us had." additional information received via email on 05mar2021 from [name] [name] received additional information from [name] the facility first began to experience this issue about 2 months ago."2 or 3" devices had this issue with poor cutting function and 3 cases were affected.All of the cases were "lap cases." [name] does not remember the dates of the procedures.The affected lot numbers are unknown.The poor cutting function issues were noted from the beginning of the case.No information has been provided regarding the tissue being cut when the issues were noted."we also got confirmation that they do not reprocess any applied products." two additional complaints have been created to document the three cases affected.The facility will be returning one event unit of unknown lot and multiple sterile units of different lot numbers.The products will be returned under complaint #2021-000465.Additional information received via email on 09mar2021 from [name] i received word from the account that they do not want to return/replace all of their applied scissors after all.They would just like to send us the one scissor they saved from a case that the surgeon said was dull, plus a second scissor that was used since.Both were from lot # 1404931, and want them sent back so we can investigate the issue and get them a response.Additional information received via phone on 26mar2021 from [name]: [name] spoke to the surgeon of the scissor complaint events.Per the surgeon, the middle of the scissors back to the scissor joint was cutting fine.The tips of the scissors were dull and/or did not appear to be closely aligned.The surgeon stated they experienced this issue in about 15 cases but only felt the need to submit complaints after the most recent events.No additional information is available about the past events as the surgeon did not take note of any details regarding these prior events.Twelve additional complaints have been made in order to document the full 15 cases.Patient status: no patient injury.No negative clinical outcomes type of intervention: multiple squeezes by the scissors were used to cut the target tissues.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any damages or non-conformances that could have contributed to the reported event.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.Applied medical continuously seeks to improve the form, function, and ease of use of its products.As part of this process, applied medical is currently researching possible enhancements intended to further minimize the potential for this type of event to occur.

• Brand Name: CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX
• Type of Device: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 11440894
• MDR Text Key: 266054370
• Report Number: 2027111-2021-00377
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• PMA/PMN Number: K062169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CB030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1