MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF33, 11X100 KII Z-THR FIOS, 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTF33
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: ruptured ectopic.Event description: the tip of a trochar shattered tonight during insertion leaving multiple plastic fragments in the umbilical wound.We think we have retrieved them all but these do not show up on xray.I was doing a ruptured ectopic tonight with my registrar and she had difficulty inserting the 10mm trochar through the umbilicus using the correct technique so we converted to verees and 5mm trochar.When we took the 10 again for suprapubic entry again we had difficulty and on removal noticed the introducer had shattered.We had not entered the abdomen suprapubically so checked and there were no fragments there.We changed trochar and inserted this without difficulty.At the end of the case we reassessed the umbilical wound and removed several plastic fragments.We had checked with xray but the trochar does not show up so we did not perform an intra-op xray.Additional information received from applied medical representative via email 05jun24: updated lot number.It was not a robotic case.At this point in time the applied medical representative was unable to retrieve further information regarding patient related, status, whether it was obturator or cannula tip that shattered and how the trocar was inserted.He will continue to reach out to the consultant.Additional information received from applied medical representative via email 07jun24: the incident happened on monday 3rd june around 2024.The 10 (11mm) trocar was inserted through a 11mm infraumbilical incision as direct entry with a 5mm zero laparoscope.It was rotated as a corkscrew technique by my registrar.I did suggest she tried a forward and backward twist technique that i use instead.However we could see if was not advancing through the abdo wall so abandoned and moved to verres and 5mm trocar which was fine.We did not notice the tip was shattered at this stage when handed back to scrub nurse.We then took it back to do a suprapubic port and again noticed poor penetration.When we removed it we noticed the fractured tip.The sleeve was intact but the tip of the trocar has disintegrated.We inspected the suprapubic wound and found no parts.We changed to new 11mm trocar which was fine with easy twisting entry.At the end we inspected the umbilical wound and removed several plastic fragments.Approx 1cm from the end of the trocar tip was missing.We removed all that we could feel or see.Some of these were the size of a grain of sugar.I have apologised to the patient and made her aware of the risk of foreign body within these 2 wounds and to report any concerns.She has recovered well and this point and has been discharged.Intervention: trochar replaced and fragments removed.Patient status: patient recovered well and has been discharged.
Event or Problem Description
Procedure performed: ruptured ectopic.Event description: the tip of a trochar shattered tonight during insertion leaving multiple plastic fragments in the umbilical wound.We think we have retrieved them all but these do not show up on xray.I was doing a ruptured ectopic tonight with my registrar and she had difficulty inserting the 10mm trochar through the umbilicus using the correct technique so we converted to verees and 5mm trochar.When we took the 10 again for suprapubic entry again we had difficulty and on removal noticed the introducer had shattered.We had not entered the abdomen suprapubically so checked and there were no fragments there.We changed trochar and inserted this without difficulty.At the end of the case we reassessed the umbilical wound and removed several plastic fragments.We had checked with xray but the trochar does not show up so we did not perform an intra-op xray.Additional information received from applied medical representative via email 05jun24: updated lot number.It was not a robotic case.At this point in time the applied medical representative was unable to retrieve further information regarding patient related, status, whether it was obturator or cannula tip that shattered and how the trocar was inserted.He will continue to reach out to the consultant.Additional information received from applied medical representative via email 07jun24: the incident happened on monday (b)(6) around 2024.The 10 (11mm) trocar was inserted through a 11mm infraumbilical incision as direct entry with a 5mm zero laparoscope.It was rotated as a corkscrew technique by my registrar.I did suggest she tried a forward and backward twist technique that i use instead.However we could see if was not advancing through the abdo wall so abandoned and moved to verres and 5mm trocar which was fine.We did not notice the tip was shattered at this stage when handed back to scrub nurse.We then took it back to do a suprapubic port and again noticed poor penetration.When we removed it we noticed the fractured tip.The sleeve was intact but the tip of the trocar has disintegrated.We inspected the suprapubic wound and found no parts.We changed to new 11mm trocar which was fine with easy twisting entry.At the end we inspected the umbilical wound and removed several plastic fragments.Approx 1cm from the end of the trocar tip was missing.We removed all that we could feel or see.Some of these were the size of a grain of sugar.I have apologised to the patient and made her aware of the risk of foreign body within these 2 wounds and to report any concerns.She has recovered well and this point and has been discharged.Intervention: trochar replaced and fragments removed.Patient status: patient recovered well and has been discharged.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with (b)(4) pieces of the obturator tip.Visual inspection confirmed the complainant¿s experience of a fractured obturator tip.Based on the condition of the returned unit, it is possible that the fractured cannula was caused by material abnormality.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.

• Brand Name: CTF33, 11X100 KII Z-THR FIOS, 6/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 19563806
• Report Number: 2027111-2024-00697
• Device Sequence Number: 6306281
• Product Code: GCJ
• UDI-Device Identifier: 00607915124212
• UDI-Public: (01)00607915124212(17)270110(30)01(10)1513370
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K041795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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 Model Number: CTF33
• Device Catalogue Number: 101476488
• Device Lot Number: 1513370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VEREES AND 5MM TROCHAR
• Patient Sex: Unknown