MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFB33, 11X100 KII SH BLD ADVFIX 6/BX; GCJ

Model Number	CFB33
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device has been returned for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: lap ectopic.Event description: "small pieces of plastic/rubber found in patients abdomen following introduction of a retrieval bag during laparoscopic surgery.Items removed from the abdomen, seal examined and the bits appear to match broken areas on the seal.Patient informed by the surgeon.Items retained by the scrub nurse." additional info received from applied team member via email on 27th july 2017: "[surgeon] wrapped [competitor's] bag around johan instrument.[scrub sister] noticed the bag was not tightly wrapped around the instrument when inserting the bag.Force was used to insert bag.[scrub sister] believes this is what caused the bits of rubber from the double duck bill to come away from the seal housing unit." patient status: no injury.
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation with two rubber fragments.Upon inspection, engineering noted fragmentation of both internal rubber components of the seal, the septum and the duckbill.The rubber fragments returned matched the missing portion the septum and the duckbill.The likely root cause of the damage to the seal is an instrument.Applied medical's instructions for use 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." applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• Brand Name: CFB33, 11X100 KII SH BLD ADVFIX 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6810291
• Report Number: 2027111-2017-01927
• Device Sequence Number: 13969717
• Product Code: GCJ
• UDI-Device Identifier: 00607915119843
• UDI-Public: (01)00607915119843(17)200301(30)01(10)1290311
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2017

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: Other
• Device Expiration Date: 03/01/2020
• Device Model Number: CFB33
• Device Catalogue Number: 101246001
• Device Lot Number: 1290311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 09/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1