TPLC - Total Product Life Cycle

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Device	forceps, biopsy, non-electric
Regulation Description	Gastroenterology-urology biopsy instrument.
Product Code	FCL
Regulation Number	876.1075
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Difficult to Open or Close	93	93
Adverse Event Without Identified Device or Use Problem	89	89
Failure to Cut	22	22
Dull, Blunt	20	20
Break	18	18
Device Contamination with Chemical or Other Material	18	18
Mechanical Problem	15	15
Material Twisted/Bent	14	14
Use of Device Problem	12	12
Insufficient Device Problem Information	9	9
Device Contaminated During Manufacture or Shipping	8	8
Human-Device Interface Problem	8	8
Device Reprocessing Problem	7	7
Entrapment of Device	6	6
Difficult to Advance	6	6
Material Integrity Problem	6	6
Appropriate Device Problem Term/Code Not Available	6	6
Difficult to Remove	6	6
Delivered as Unsterile Product	5	5
Physical Resistance/Sticking	4	4
Detachment of Device or Device Component	4	4
Mechanical Jam	3	3
Device Damaged Prior to Receipt by User	3	3
Contamination	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Device Damaged Prior to Use	3	3
Material Deformation	2	2
Residue After Decontamination	2	2
Failure to Clean Adequately	2	2
Unsealed Device Packaging	2	2
Structural Problem	1	1
Product Quality Problem	1	1
Retraction Problem	1	1
Stretched	1	1
Difficult to Insert	1	1
No Apparent Adverse Event	1	1
Fracture	1	1
Device Dislodged or Dislocated	1	1
Failure to Obtain Sample	1	1
Loose or Intermittent Connection	1	1
Improper or Incorrect Procedure or Method	1	1
Wrong Label	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	202	203
Hemorrhage/Blood Loss/Bleeding	49	49
No Known Impact Or Consequence To Patient	39	39
No Consequences Or Impact To Patient	29	29
Insufficient Information	20	20
Pancreatitis	16	16
Unspecified Tissue Injury	13	13
Tissue Damage	10	10
Hematoma	10	10
Perforation	9	9
Unspecified Hepatic or Biliary Problem	9	9
Foreign Body In Patient	8	8
Blood Loss	7	7
Hematuria	6	6
Laceration(s)	6	6
Pneumothorax	5	5
No Patient Involvement	5	5
Excessive Tear Production	4	4
Cholangitis	4	4
Urinary Tract Infection	3	3
Sepsis	3	3
Dysuria	3	3
No Code Available	3	3
Gastrointestinal Hemorrhage	3	3
Inflammation	3	3
Tachycardia	3	3
Renal Failure	3	3
Device Embedded In Tissue or Plaque	2	2
Fistula	2	2
Respiratory Failure	2	2
Pneumonia	2	2
Dyspnea	2	2
Vomiting	2	2
Urinary Retention	2	2
Septic Shock	2	2
Unspecified Mental, Emotional or Behavioural Problem	2	2
Fever	2	2
Cramp(s) /Muscle Spasm(s)	2	2
No Information	2	2
Death	2	2
Liver Failure	2	2
Hypovolemic Shock	2	2
Abdominal Pain	2	2
Discomfort	1	1
Micturition Urgency	1	1
Chest Pain	1	1
Stomach Ulceration	1	1
Pain	1	1
Hematemesis	1	1
Angina	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Jul-31-2026
2	Richard Wolf GmbH	II	Apr-24-2023